Conditions: Neovascular Age Related Macular Degeneration
Keywords: ARMD AMD exudative AMD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.

Detailed description:

Arms:
arm 1: Ranibizumab injections every month for 12 months. arm 2: Ranibizumab injections monthly for 4 months then as needed thereafter.

Interventions: intervention 1: OCT, Multifocal ERG, Microperimetry intervention 2: Ranibizumab Ophthalmic
Intervention descriptions: intervention 1: OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12.

Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab.

Multifocal ERG done at the same monthly visits as the microperimetry. intervention 2: 0.5 mg ranibizumab vs 2.0 mg ranibizumab

Protocol document: