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Clinical Trial Results:
Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month Phase 2a open label study of Fovista™ (anti-PDGF therapy) administered in combination with anti-VEGF therapy

Summary
EudraCT number	2015-000519-42
Trial protocol	FR IT
Global end of trial date	06 Jan 2017

Results information
Results version number	v1(current)
This version publication date	28 Nov 2018
First version publication date	28 Nov 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

OPH1008

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Ophthotech Corporation

Sponsor organisation address

One Penn Plaza, Suite 3520 , New York, United States, NY 10119

Public contact

Fang Li, Ophthotech Corporation, +1 212-845-8219, fang-li@ophthotech.com

Scientific contact

Fang Li, Ophthotech Corporation, +1 212-845-8219, fang-li@ophthotech.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Jan 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jan 2017

Global end of trial reached?

Yes

Global end of trial date

06 Jan 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess the safety and biomarker responses of various regimens of Fovista™ when administered in combination with anti-VEGF agents, in treatment naïve and treatment experienced neovascular AMD subjects.

Protection of trial subjects

All subjects signed the informed consent before undergoing any study-related procedure.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Mar 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 15

Country: Number of subjects enrolled

Italy: 17

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study was conducted in 6 centers in France and 6 centers in Italy between 29 March 2016 and 06 January 2017. Written informed consent was obtained before any of the Screening details listed below were performed.

Screening details

Medical & ophthalmologic history, protocol refraction & visual acuity, ophthalmologic examination, Goldmann Applanation Tonometry, color fundus photographs, Fluorescein Angiograms, Optical Coherence Tomography (OCT), Indocyanine Green and OCT angiography, laboratory & pregnancy tests & concomitant medication were assessed at screening prior to Day1

Period 1 title

18 Months (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Treatment naive, simultaneous regimen

Arm description

Treatment naive subjects randomized to simultaneous regimen received IVT Fovista + IVT anti-VEGF agent administered on the same day.

Arm type

Experimental

Investigational medicinal product name

Fovista

Investigational medicinal product code

Other name

E10030, pegpleranib

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent (i.e., Lucentis, Eylea or Avastin). All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected visual acuity (BCVA, hereafter referred to as VA) change from the prior visit.

Investigational medicinal product name

Avastin

Investigational medicinal product code

Other name

Bevacizumab

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent Avastin. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the VA change from the prior visit.

Investigational medicinal product name

Eylea

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent Eylea. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the VA change from the prior visit.

Investigational medicinal product name

Lucentis

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent Lucentis. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the VA change from the prior visit.

Treatment naive, pre-treatment regimen

Arm description

Treatment naive subjects randomized to pre-treatment regimen received initial administration of IVT Fovista 1.5 mg monotherapy and 48 hours later (2 days) followed by the administration of IVT Fovista 1.5 mg and IVT anti-VEGF agent administered in combination on the same day.

Arm type

Experimental

Investigational medicinal product name

Fovista

Investigational medicinal product code

Other name

E10030, pegpleranib

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent (i.e., Lucentis, Eylea or Avastin). All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Investigational medicinal product name

Avastin

Investigational medicinal product code

Other name

Bevacizumab

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent Avastin. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Investigational medicinal product name

Eylea

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent Eylea. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Investigational medicinal product name

Lucentis

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent Lucentis. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Treatment experienced, simultaneous regimen

Arm description

Treatment experienced subjects randomized to simultaneous regimen, received IVT Fovista 1.5 mg and IVT anti-VEGF agent administered in combination on the same day.

Arm type

Experimental

Investigational medicinal product name

Fovista

Investigational medicinal product code

Other name

E10030, pegpleranib

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Investigational medicinal product name

Avastin

Investigational medicinal product code

Other name

Bevacizumab

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent Avastin. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the VA change from the prior visit.

Investigational medicinal product name

Eylea

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent Eylea. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the VA change from the prior visit.

Investigational medicinal product name

Lucentis

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent Lucentis. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the VA change from the prior visit.

Treatment experienced, pre-treatment regimen

Arm description

Treatment experienced subjects randomized to pre-treatment regimen received initial administration of IVT Fovista 1.5 mg monotherapy and 48 hours later (2 days) followed by the administration of IVT Fovista 1.5 mg and IVT anit VEGF agent administered in combination on the same day.

Arm type

Experimental

Investigational medicinal product name

Fovista

Investigational medicinal product code

Other name

E10030, pegpleranib

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent (i.e., Lucentis, Eylea or Avastin). All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Investigational medicinal product name

Avastin

Investigational medicinal product code

Other name

Bevacizumab

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent Avastin. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Investigational medicinal product name

Eylea

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent Eylea. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Investigational medicinal product name

Lucentis

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

There were 2 cohorts of subjects in this trial:treatment experienced and treatment naïve. Subjects in each cohort were randomized in a 1:1 ratio to either Simultaneous Treatment or Pre-treatment Regimen. Treatment experienced subjects continued to receive the same anti-VEGF agent that they received prior to entry into the study (i.e., Lucentis, Eylea or Avastin). Treatment naïve subjects were randomized in a 1:1:1 ratio to Lucentis, Eylea, or Avastin as the anti-VEGF agent. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent Lucentis. All subjects were treated every month for the first 5 months (Baseline, Months 1,2,3,4), followed by treatment every 3 months (Months 7,10,13, and 16), for a total of 18 months. During the non-treatment months, subjects could be treated according to the best corrected VA change from the prior visit.

Number of subjects in period 1	Treatment naive, simultaneous regimen	Treatment naive, pre-treatment regimen	Treatment experienced, simultaneous regimen	Treatment experienced, pre-treatment regimen
Started	14	14	2	2
Completed	0	0	0	0
Not completed	14	14	2	2
Sponsor decision-study terminated early	14	14	2	2

Baseline characteristics

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Reporting group title

Treatment naive, simultaneous regimen

Reporting group description

Treatment naive subjects randomized to simultaneous regimen received IVT Fovista + IVT anti-VEGF agent administered on the same day.

Reporting group title

Treatment naive, pre-treatment regimen

Reporting group description

Reporting group title

Treatment experienced, simultaneous regimen

Reporting group description

Treatment experienced subjects randomized to simultaneous regimen, received IVT Fovista 1.5 mg and IVT anti-VEGF agent administered in combination on the same day.

Reporting group title

Treatment experienced, pre-treatment regimen

Reporting group description

Reporting group values	Treatment naive, simultaneous regimen	Treatment naive, pre-treatment regimen	Treatment experienced, simultaneous regimen	Treatment experienced, pre-treatment regimen	Total
Number of subjects	14	14	2	2	32
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	2	1	0	0	3
From 65-84 years	9	9	1	2	21
85 years and over	3	4	1	0	8
Age continuous
Units: years
arithmetic mean (standard deviation)	75.6 ( 9.55 )	76.8 ( 8.42 )	85.5 ( 2.12 )	80.5 ( 2.12 )	-
Gender categorical
Units: Subjects
Female	7	8	1	0	16
Male	7	6	1	2	16

End points

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Reporting group title

Treatment naive, simultaneous regimen

Reporting group description

Treatment naive subjects randomized to simultaneous regimen received IVT Fovista + IVT anti-VEGF agent administered on the same day.

Reporting group title

Treatment naive, pre-treatment regimen

Reporting group description

Reporting group title

Treatment experienced, simultaneous regimen

Reporting group description

Treatment experienced subjects randomized to simultaneous regimen, received IVT Fovista 1.5 mg and IVT anti-VEGF agent administered in combination on the same day.

Reporting group title

Treatment experienced, pre-treatment regimen

Reporting group description

Primary: Change in Visual Acuity

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End point title

Change in Visual Acuity ^[1]

End point description

End point type

Primary

End point timeframe

Severe Visual Acuity Loss (Proportion of subjects with >15 letter loss at Months 12 and 18)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The study was terminated early. Due to the small number of subjects enrolled and treated in the study, summary statistics of change in visual acuity over time was not conducted.

End point values	Treatment naive, simultaneous regimen	Treatment naive, pre-treatment regimen	Treatment experienced, simultaneous regimen	Treatment experienced, pre-treatment regimen
Number of subjects analysed	14	14	2	2
Units: Proportion of subjects	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From Randomization at Day 1 (14 days after Screening) until end of study.

Adverse event reporting additional description

AEs were reported on the safety population (all subjects who received at least 1 dose of study drug [Fovista]).Causally related occurrences included both events reported as: related to injection procedure and related to study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

Treatment naive, simultaneous regimen

Reporting group description

Treatment naive cohort, simultaneous regimen. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent (i.e., Lucentis, Eylea or Avastin).

Reporting group title

Treatment naive, pre-treatment regimen

Reporting group description

Treatment naive cohort, pre-treatment regimen. Subjects received IVT Fovista (1.5 mg/eye) monotherapy and 48 hours later, IVT Fovista (1.5 mg/eye) in combination with anti-VEGF agent (i.e., Lucentis, Eylea or Avastin).

Reporting group title

Treatment experienced, simultaneous regimen

Reporting group description

Treatment naive cohort, simultaneous regimen. Subjects received the Fovista injection first (1.5 mg/eye), followed by the anti-VEGF agent (i.e., Lucentis, Eylea or Avastin).

Reporting group title

Treatment experienced,pre-treatment regimen

Reporting group description

Serious adverse events	Treatment naive, simultaneous regimen	Treatment naive, pre-treatment regimen	Treatment experienced, simultaneous regimen	Treatment experienced,pre-treatment regimen
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Treatment naive, simultaneous regimen	Treatment naive, pre-treatment regimen	Treatment experienced, simultaneous regimen	Treatment experienced,pre-treatment regimen
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 2 (0.00%)	0 / 2 (0.00%)
Investigations
Intraocular pressure increased
subjects affected / exposed	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 2 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

21 Oct 2015

The rationale for the changes incorporated in OPH1008 Amendment A was with regard to the number of study visits where the “pre-treatment” regimen was administered. The original OPH1008 protocol design included the “pre-treatment” regimen administered at all study visits after the Induction Phase. Amendment A modified the treatment schedule to administer the “pre-treatment” regimen for the first 5 months of the study (Baseline, Month 1-Month 4). Beginning at Month 5, subjects were to be administered the simultaneous treatment regimen only. The “pre-treatment” regimen was now only administered during the Induction Phase of the study. In addition to the changes described above, a clarification to one of the inclusion criteria was made. There was also a change in the company responsible for Data management.

10 Jun 2016

Amendment B included the update of the ophthalmic inclusion criteria. The definition of active CNV was modified to remove requirement for fluid as objective of protocol was to assess biomarker responses of various regimens of Fovista™ when administered in combination with anti-VEGF agents. Using Snellen acuity before and after the prior anti-VEGF therapy maintains consistent visual acuity assessment, avoiding the potential for changes in visual acuity due to testing conditions. Amendment B included the update of both ophthalmic inclusion and exclusion criteria with respect to the requirement for number of prior intravitreal injections, criteria were modified to be consistent with European labeling of anti-VEGF agents where up to 3 loading doses are required. In addition, the exclusion criterion for HbA1c value ≥ 6.5% was removed as the safety profile in subjects with high HbA1c values was unremarkable. Only subjects with definitive diagnosis of diabetes mellitus or diabetic retinopathy were to be excluded. The section of the protocol concerning previous and concomitant therapy was modified to reflect the changes in the inclusion and exclusion criteria with respect to the requirement for number of prior intravitreal injections (modified to be consistent with European labeling of anti-VEGF agents where up to 3 loading doses are required). The amendment also included corrections in the text of the protocol and other administrative

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The study was terminated early (due to the lack of efficacy from two controlled phase 3 studies [OPH1002 and OPH1003]) after the enrollment and treatment of 32 subjects, no subject completed the 18-month study.

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Clinical trials

Clinical Trial Results:
Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month Phase 2a open label study of Fovista™ (anti-PDGF therapy) administered in combination with anti-VEGF therapy

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in Visual Acuity

Primary: Change in Visual Acuity

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month Phase 2a open label study of Fovista™ (anti-PDGF therapy) administered in combination with anti-VEGF therapy

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in Visual Acuity

Primary: Change in Visual Acuity

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month Phase 2a open label study of Fovista™ (anti-PDGF therapy) administered in combination with anti-VEGF therapy