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

Study Overview
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Brief Summary
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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.

Official Title
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Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration

Conditions
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Neovascular Age Related Macular Degeneration

Intervention / Treatment
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* Device: OCT, Multifocal ERG, Microperimetry
* Drug: Ranibizumab Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age greater or equal to 50 years old. Patients with active neovascular AMD Exclusion Criteria: Pregnancy (Positive pregnancy test) or lactation. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) Previous PDT therapy Previous intravitreal steroid therapy within last 3 months Previous anti-VEGF therapy in the past month

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monthly<br>Ranibizumab injections every month for 12 months. | Device: OCT, Multifocal ERG, Microperimetry<br>* 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.<br>Drug: Ranibizumab Ophthalmic<br>* 0.5 mg ranibizumab vs 2.0 mg ranibizumab<br>|
| Active Comparator: As Needed<br>Ranibizumab injections monthly for 4 months then as needed thereafter. | Device: OCT, Multifocal ERG, Microperimetry<br>* 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.<br>Drug: Ranibizumab Ophthalmic<br>* 0.5 mg ranibizumab vs 2.0 mg ranibizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multifocal Electroretinography N1-P1 Amplitude | As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1). | One Year | 
| Microperimetry Mean Sensitivity |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity |  | One Year | 
| Central Foveal Thickness on Optical Coherence Tomography |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARMD, AMD, exudative AMD