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

Retina Macula Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Neovascular Age Related Macular Degeneration

Treatments: Drug: Ranibizumab Ophthalmic; Device: OCT, Multifocal ERG, Microperimetry

Study type: Interventional

Funder types: Other

Identifiers

NCT00764738

FVF4495s

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Monthly

Active Comparator group

Description:

Ranibizumab injections every month for 12 months.

Treatment:

Drug: Ranibizumab Ophthalmic

Device: OCT, Multifocal ERG, Microperimetry

As Needed

Active Comparator group

Description:

Ranibizumab injections monthly for 4 months then as needed thereafter.

Treatment:

Drug: Ranibizumab Ophthalmic

Device: OCT, Multifocal ERG, Microperimetry