Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 21
- Primary Endpoint
- Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
Study Overview
Brief Summary
Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.
Detailed Description
The aim of this study is to assess whether the retina of some patients has dried up after the first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to determine the proportion of these patients The analysis of the characteristics could help identify a morphotype that would predict whether and when the retina will dry up within the first 3 months of treatment. For some patients having an early drying-up, the third monthly injection might be not necessary 50 naïve patients will be included and will receive a monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional characteristics will be recorded at each visit and will be analyzed. The rate of patients with dry SD-OCT will be assessed.
The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®) 2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or Fluorescein Angiography are performed
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women ≥ 50 years of age
- •Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affects the fovea as evidenced by FA in the study eye
- •Signed Informed Consent
- •Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
Exclusion Criteria
- •Prior treatment with anti-VEGF therapy in the study eye
- •Active or suspected ocular or periocular infection.
- •Active severe intraocular inflammation
Arms & Interventions
Aflibercept 2mg Intravitreal injection
2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period
Intervention: Intravitreal injection (Procedure)
Outcomes
Primary Outcomes
Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
Time Frame: 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg
Secondary Outcomes
- Time to get a dry SD-OCT after initiation of a treatment by Aflibercept(Every 2 weeks from treatment initiation (inclusion) to week 12)
- Evolution of morphological and visual modification under Aflibercept (EYLEA®)(Every 2 weeks from treatment initiation (inclusion) to week 12)
- Occurence of pigment epithelial detachment(Every 2 weeks from treatment initiation (inclusion) to week 12)
- Evolution of retinal hemorrhage if any(Every 2 weeks from treatment initiation (inclusion) to week 12)
- Evolution in the atrophic lesions(Every 2 weeks from treatment initiation (inclusion) to week 12)
- Occurence the central Retinal Thickness(Every 2 weeks from treatment initiation (inclusion) to week 12)