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

NCT00668785 | Terminated Phase 2 Results

• 1 other identifier: FVF3848s
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Proliferative Diabetic Retinopathy; Macular Edema

Keywords

Ranibizumab; Proliferative Diabetic Retinopathy; Macular Edema following Panretinal Photocoagulation; Safety and Efficacy; Intravitreal Injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  March 2010

• Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point

  March 2010

Study Arms (1)

Ranibizumab

EXPERIMENTAL

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.

Drug: ranibizumab

Interventions

ranibizumab DRUG

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

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Jumper, J. Michael, M.D.: lead
• Genentech, Inc.: collaborator

Study Sites (1)

West Coast Retina Medical Group Inc.

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Study was terminated by Sponsor and Investigator due to low enrollment. Data not analyzed. Technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: J. Michael Jumper, MD
• Organization: West Coast Retina Medical Group, Inc.

jmjumper@westcoastretina.com

415-972-4600

Study Officials

• J. Michael Jumper, M.D.

  West Coast Retina Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: March 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: March 1, 2012
• Last Updated: March 5, 2019
• Results First Posted: April 24, 2015

Record last verified: 2019-02

Locations

US (1)