Trial Condition(s):
Macular degeneration
Efficacy and safety of two different aflibercept regimens in subjects with neovascular age-related macular degeneration (nAMD)
Bayer Identifier:
16598
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)
Inclusion Criteria
- The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study): -- Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment. -- The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment. -- Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment. - Men and women >= 51 years of age - The subject’s history of aflibercept treatment meets ALL of the following: -- Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed -- Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks
Exclusion Criteria
- Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept. -- Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye -- Subretinal hemorrhage that was: a) 50% or more of the total lesion area, or b) if the blood was under the fovea, and c) the blood under the fovea was 1 or more disc areas in size in the study eye. -- Scar or fibrosis making up more than 50% of the total lesion in the study eye. -- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye. -- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye. -- Causes of CNV other than AMD in the study eye.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Trial Design
An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of 2 mg Aflibercept administered by intravitreal injections using two different treatment regimens to subjects with neovascular age-related macular degeneration (nAMD).
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity (EDTRS BCVA) letter score for the study eyeTimeframe: Week 52
Secondary Outcome
- Number of participants with adverse events as measure of safety and tolerabilityTimeframe: Week 52 and Week 76
- Proportion of subjects maintaining vision (i.e. loss of < 15 letters) in the study eyeTimeframe: Week 52
- Proportion of subjects who gained from baseline ≥ 5 letters in the study eyeTimeframe: Week 52
- Mean change from baseline in central retinal thickness (CRT) in the study eyeTimeframe: Week 52
- Mean change from baseline in choroidal neovascularization (CNV) area in the study eyeTimeframe: Week 52
- Proportion of subjects who lost ≥ 30 lettersTimeframe: Week 52
- Mean change from baseline in total score for National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25)Timeframe: Week 52
Additional Information
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