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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00668785
• Other study ID #: FVF3848s
• Status: Terminated
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: March 2012

Study information

• Verified date: February 2019
• Source: Jumper, J. Michael, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	West Coast Retina Medical Group Inc.	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Jumper, J. Michael, M.D.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)	No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.	March 2010
Secondary	Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.	No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.	March 2010
Secondary	Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point	No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.	March 2010