Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration

Conditions

• Neovascular Age Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• OCT, Multifocal ERG, Microperimetry — DEVICE
  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.
• Ranibizumab Ophthalmic — DRUG
  0.5 mg ranibizumab vs 2.0 mg ranibizumab

Study Details

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.

Key Dates

First listed

Oct 2, 2008

Start date

Oct 31, 2008

Status verified

Sep 2020

Primary completion

Nov 30, 2011

Completion

Nov 30, 2011

Study Design

Enrollment

91 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Monthly
  Ranibizumab injections every month for 12 months.
• Active Comparator: As Needed
  Ranibizumab injections monthly for 4 months then as needed thereafter.

Primary Outcome Measure

Multifocal Electroretinography N1-P1 Amplitude [ Time Frame: One Year ]

Locations (1)

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