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

Phase 2

Completed

• Conditions: Neovascular Age Related Macular Degeneration
• Interventions: Device: OCT, Multifocal ERG, Microperimetry; Drug: Ranibizumab Ophthalmic

• Registration Number: NCT00764738
• Lead Sponsor: Retina Macula Institute

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

Not available

Study Timeline

• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study Start: 2008-10
• Study First Posted: 2008-10-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2020-08-16
• Results First Submitted QC: 2020-08-16
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Results First Posted: 2020-09-02
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
As Needed	Ranibizumab Ophthalmic	Ranibizumab injections monthly for 4 months then as needed thereafter.
Monthly	Ranibizumab Ophthalmic	Ranibizumab injections every month for 12 months.
As Needed	OCT, Multifocal ERG, Microperimetry	Ranibizumab injections monthly for 4 months then as needed thereafter.
Monthly	OCT, Multifocal ERG, Microperimetry	Ranibizumab injections every month for 12 months.

Primary Outcome Measures

Name	Time	Method
Multifocal Electroretinography N1-P1 Amplitude	One Year	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).
Microperimetry Mean Sensitivity	One Year

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	One Year
Central Foveal Thickness on Optical Coherence Tomography	One Year

Trial Locations

Locations (1)

Retina Macula Institute; 🇺🇸 Torrance, California, United States