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

Completed · Phase 2/Phase 3

Conditions studied: Neovascular Age Related Macular Degeneration

In brief

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 facts

Study ID

NCT00764738

Run by

Retina Macula Institute

People needed

91

Starts

2008-10-01

Expected to finish

2011-11-01

Last updated by the study team

2020-09-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retina Macula Institute — Torrance, California, United States

Full record on ClinicalTrials.gov

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