Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01170767
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years old
* Affected by neovascular retrofoveal AMD whatever the subtype, unilateral or bilateral (the eye included will be chosen by the investigator and the patient);
* Best corrected VA for the studied eye ranging between 20/32 (6.3/10) and 20/320 (0.6/10) with ETDRS scale
* Size of lesion \< 12 disk area
* In case of occult neovessels, proof required of recent development of the lesion: loss of VA of at least 5 letters ETDRS (equivalent one line) in the last 3 months OR appearance of a subretinal heamorrhage OR increase in the size of the lesion (\> 10%) using fluoresceinic angiography during the last month by comparison with the last 3 months OR appearance of OCT criteria of macular oedema type, serous separation of neuro-epithelium, separation of the pigmented epithelial during the last month
* Effective birth control for sexually active female
* Signed informed consent.
Exclusion Criteria:
* Previous or actual treatment with intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab or pegaptanib) in the studied eye
* Other healing treatment in the studied eye during the last 3 months before the first injection
* Medical history of photocoagulation in the studied eye
* Involvement in another clinical study (studied eye and/or the other eye)
* Subretinal haemorrhage reaching the fovea centre, with a size \> 50% of the lesion area
* Fibrosis or retrofoveal retinal atrophy in the studied eye
* Retinal pigment epithelial tear reaching the macula in the studied eye
* Choroidal neovascularisation not related to a DMLA in the studied eye
* Medical history of intravitreal medical device in the studied eye
* Active or suspected ocular or peri-ocular infection
* Serious active intra-ocular inflammation in the studied eye
* Medical history of auto-immune or idiopathic uveitis
* Proved diabetic retinopathy
* Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
* Medical history of intra-ocular surgery within 2 months before the first injection in the studied eye
* Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
* Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
* Known hypersensitivity to ranibizumab, bevacizumab, or another drug composite of the medicinal products used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
* Arterial hypertension that is not controlled by an appropriate treatment
* Previous or actual treatment with systemic administration of bevacizumab
* Follow up not possible during 12 months
* No affiliation to the French national health insurance program.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01170767
Study Brief:
Protocol Section:
NCT01170767