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

NCT00764738 | Completed Phase 2 Results DMC

• 1 other identifier: FVF4495s
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Age Related Macular Degeneration

Keywords

ARMD; AMD; exudative AMD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Best Corrected Visual Acuity

  One Year

• Central Foveal Thickness on Optical Coherence Tomography

  One Year

Study Arms (2)

Monthly

ACTIVE COMPARATOR

Ranibizumab injections every month for 12 months.

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

As Needed

ACTIVE COMPARATOR

Ranibizumab injections monthly for 4 months then as needed thereafter.

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

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.

As Needed; Monthly

Ranibizumab Ophthalmic DRUG

0.5 mg ranibizumab vs 2.0 mg ranibizumab

As Needed; Monthly

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Retina Macula Institute: lead

Study Sites (1)

Retina Macula Institute

Torrance, California, 90503, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Dr. Ron Gallemore
• Organization: Retina Macula Institute

rongallemoremd@gmail.com

Study Officials

• Ron P. Gallemore, MD, PhD

  Retina Macula Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 22, 2020
• Results First Posted: September 2, 2020

Record last verified: 2020-09

Locations

US (1)