E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with exudative AMD with focal vitreomacular adhesion |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with an eye disease called wet Age-Related
Macular Degeneration (AMD) with local vitreomacular adhesion |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060823 |
E.1.2 | Term | Choroidal neovascularisation |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051065 |
E.1.2 | Term | Vitreomacular traction syndrome |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015902 |
E.1.2 | Term | Exudative senile macular degeneration of retina |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and preliminary efficacy of intravitreal ocriplasmin in patients with exudative AMD with focal vitreomacular adhesion |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male or female patients aged > 50
-Presence of focal vitreomacular adhesion measured by OCT.
-Diagnosis of active primary or recurrent subfoveal CNV secondary to
AMD, including those with predominantly classic, minimally classic or
occult lesions with no classic component.
-The total area of CNV (including both classic and occult components)
encompassed within the lesion must be > 50% of the total lesion area
-The total lesion area must be < 12 disc areas
- Subjects who have previously received at least three anti-angiogenic
injections (Lucentis ® or Avastin®) in the study eye
-Subjects with visual acuity of 20/32 to 20/200 in the study eye
-Written informed consent obtained from the patient prior to inclusion in
the study |
|
E.4 | Principal exclusion criteria |
-Evidence of complete macular PVD in the study eye on biomicroscopy,
B-scan ultrasound or OCT prior to planned study drug injection
-Patients with vitreous haemorrhage which precludes either of the
following: visualization of the posterior pole by visual inspection OR
adequate assessment of the macula by either OCT and/or fluorescein
angiography in the study eye or other opacities precluding visualisation
of the fundus.
- Subjects who have previously received more than 9 anti-angiogenic
agent injections (whether Lucentis® or Avastin® or other antiangiogenic
agent) in the study eye
-Patients with history of rhegmatogenous retinal detachment or PVR in
the study eye
-Patients with high myopia (> 8D) or aphakia in the study eye
-Patients who have had ocular surgery in the study eye in the prior three
months
-Patients who have had a vitrectomy in the study eye at any time.
-Patients with uncontrolled glaucoma in the study eye (defined as
intraocular pressure > 26 mm Hg in spite of treatment with antiglaucoma
medication)
-Intravitreal injection of any drug or photodynamic therapy in the study
eye in the previous 10 days or such planned treatment in the 10 days
following study drug injection
-Patients who are pregnant or of child-bearing potential not utilizing an
acceptable form of contraception. Acceptable methods of birth control
include intrauterine device, oral, implanted, or injected contraceptives,
and barrier methods with spermicide.
-Patients who, in the investigators view, will not complete all visits and
investigations
-Patients who have participated in an investigational drug study within
the past 30 days
-Patients who have previously participated in this trial |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoint:
Post-injection complications (including worsening visual acuity, change in vision, worsening macular edema, vitreous hemorrhage, retinal tear or detachments, inflammation, IOP alterations)
Efficacy Primary endpoint
-Proportion of patients with release of focal vitreomacular adhesion by day 28 as determined by masked Central Reading Center evaluation of imaging
Efficacy Secondary endpoint:
-Vitreomacular adhesion status and PVD status at visits other than day 28 post-injection visit
-Assessment of PVD status
-Macular thickness
-Visual Acuity
-Central retinal/lesion thickness
-Membrane growth
-Size of fluorescein leakage
-Number of patients requiring additional therapy
-Number of Lucentis®/Avastin® injections required during the study
-Initial Lucentis®/Avastin® free interval
-VFQ-25 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 28 post injection (protocol section 4.2.2) |
|
E.5.2 | Secondary end point(s) |
-Vitreomacular adhesion status at visits other than day 28 postinjection
visit
-Assessment of PVD status
-Macular thickness
-Visual Acuity
-Central retinal/lesion thickness
-Membrane growth
-Size of fluorescein leakage
-Number of subjects requiring additional therapy
-Number of Lucentis®/Avastin® injections required during the study
-Initial Lucentis®/Avastin® free interval
-VFQ-25
(protocol section 4.3.1) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at study visits 3, 4, 5, 6, 7 and 8 (protocol section 4.3 and Appendix 1) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
France |
Germany |
Italy |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is defined as the last visit of the last subject, unless the Safety Committee recommends premature termination of the trial as a result of safety concerns |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 25 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |