Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

NCT ID: NCT00668785

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-03-31

Brief Summary

This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.

Detailed Description

Levels of VEGF are elevated in eyes wth Diabetic Macular Edema and the expression of VEGF was found to be elevated temporarily following the photocoagulation of human Retinal Pigment Epithelial (RPE) cells. Ranibizumab (Lucentis TM, Genentech) is an anti-VEGF antibody shown to have properties to prevent macular edema. We hypothesize that VEGF inhibition can effectively treat PRP-induced macular edema, thereby minimizing post-PRP vision loss.

Subjects who meet eligibility criteria will receive 0.5mg ranibizumab administered 7-14 days post-PRP. Additional intravitreal injections of 0.5 mg of ranibizumab at Day 30 and/or Day 60 may be also be administered. All subjects will be followed for 90 days for safety and efficacy assessments. There is no placebo or sham arm of this trial.

Conditions

Proliferative Diabetic Retinopathy; Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab

Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Interventions

ranibizumab

Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility Criteria

Inclusion Criteria

• Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography AND 7-14 day post-PRP OCT
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age 21 years or older
• Previously untreated PDR patients with high risk characteristics who develop edema within 7-14 days post PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>10% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP macular volume).

Exclusion Criteria

• Pregnancy (positive pregnancy test) prior to enrollment in the study
• 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
• Pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP
• Neovascularization of the iris or neovascular glaucoma
• Increased central foveal thickness for any other reason
• Concurrent macular diseases that could confound the results of this study
• Prior vitrectomy in the study eye
• Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Jumper, J. Michael, M.D.

INDIV

Sponsor Role: lead

Responsible Party

J. Michael Jumper, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Michael Jumper, M.D.

Role: PRINCIPAL_INVESTIGATOR

West Coast Retina Medical Group, Inc.

Locations

West Coast Retina Medical Group Inc.

San Francisco, California, United States

Countries

United States

Other Identifiers

FVF3848s

Identifier Type: -

Identifier Source: org_study_id