E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Percentage of patients showing regression of retinal neovascularization between baseline and month 12 in the Aflibercept group versus laser group |
|
E.1.1.1 | Medical condition in easily understood language |
proliferative diabetic retinopathy |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036857 |
E.1.2 | Term | Proliferative diabetic retinopathy |
E.1.2 | System Organ Class | 100000004853 |
|
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 |
Percentage of patients showing regression of retinal neovascularization between baseline and month 12 in the Aflibercept group versus laser group |
|
E.2.2 | Secondary objectives of the trial |
Percentage of patients showing regression of retinal neovascularization between baseline and month 3 and 6 in the Aflibercept group versus laser group.
- Variation of central macular thickness on SD-OCT between baseline months 3, 6 and 12.
- Mean visual acuity variation (ETDRS score) between baseline and month 12.
- Percentage of patients requiring vitrectomy for persistent intravitreal hemorrhage (more than 1 month) or retinal detachment at month 12 into the two groups.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diabetic patients with proliferative diabetic retinopathy
- Aged 18 years old or more
- Best corrected visual acuity score ≥ 35 letters
- Glycosylated hemoglobin rate < 11% at inclusion
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 105 mmHg at inclusion
- Clear ocular media allowing fundus examination
|
|
E.4 | Principal exclusion criteria |
- Any history of retinal laser photocoagulation
- Any history of intravitreal injection
- Any history of vitrectomy
- proliferative diabetic retinopathy associated to retinal detachment
- proliferative diabetic retinopathy associated to fibrovascular proliferation
- florid proliferative diabetic retinopathy
- Allergy to fluorescein
- Active infectious disease
- Any significant recent (less than 3 months) cardiovascular disorder (angina pectoris, myocardial infarction, renal failure)
- Any ocular disorder that could prevent retinal examination (cataract)
- Significant macular edema ≥350 µm.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients showing regression of retinal neovascularization in the Aflibercept group versus laser group |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Percentage of patients showing regression of retinal neovascularization .
- Variation of central macular thickness on SD-OCT
- Mean visual acuity variation
- Percentage of patients requiring vitrectomy for persistent intravitreal hemorrhage or retinal detachment |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |