Intense Treatment Regimen With Intravitreal Aflibercept Injection
United States30 participantsStarted 2018-09-11
Plain-language summary
This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Age ≥ 50 years
* Choroidal neovascularization related to age-related macular degeneration
* Prior treatment with any anti-VEGF agent for ≥ 12 months
* Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days
* Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
* Monocular patients
* Patients with a previous history of macular thermal laser or PDT
* Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Active intraocular inflammation (grade trace or above) in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks wi…
What they're measuring
1
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT03594461
SponsorVitreous -Retina- Macula Consultants of New York