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Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
This study is currently recruiting participants.
Verified by Jumper, J. Michael, M.D., April 2008
Sponsors and Collaborators: Jumper, J. Michael, M.D.
Genentech
Information provided by: Jumper, J. Michael, M.D.
ClinicalTrials.gov Identifier: NCT00668785
  Purpose

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


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Macular Edema
Drug: ranibizumab
Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders
Drug Information available for: Ranibizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

Further study details as provided by Jumper, J. Michael, M.D.:

Primary Outcome Measures:
  • 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.)

Secondary Outcome Measures:
  • 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.
  • Percentage of patients that maintain pre-PRP visual acuity at the 3 month time point
  • Change between baseline and each efficacy outcome assessment in best-corrected ETDRS visual acuity score (e.g. mean visual acuity score)
  • Change in the hyperfluorescence of the macula as assessed by 2 readers blinded to the 2 arms of the study.
  • Injection-related events including severe uveitis, infectious endophthalmitis, non-infectious endophthalmitis, retinal detachment, and vitreous hemorrhage.

Estimated Enrollment: 30
Study Start Date: March 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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 be randomized to either ranibizumab 0.5mg or observation at a ratio of 2:1. All subjects will be followed for 90 days for safety and efficacy assessments. There is no placebo or sham arm of this trial.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (>20% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>20% 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668785

Contacts
Contact: Jennifer M Rose, B.S. 415-972-4608 jrose@westcoastretina.com
Contact: Brandi L. Teske 415-972-4606 bteste@westcoastretina.com

Locations
United States, California
West Coast Retina Medical Group Inc. Recruiting
San Francisco, California, United States, 94107
Contact: Jennifer M Rose, B.S.     415-972-4608     jrose@westcoastretina.com    
Contact: Brandi L Teske     415-972-4606     bteske@westcoastretina.com    
Sub-Investigator: Robert N Johnson, M.D.            
Sub-Investigator: H. Richard McDonald, M.D.            
Sub-Investigator: Arthur D Fu, M.D.            
Sub-Investigator: Alex T Bui, M.D.            
Sub-Investigator: Richard Roe, M.D.            
Sponsors and Collaborators
Jumper, J. Michael, M.D.
Genentech
Investigators
Principal Investigator: J. Michael Jumper, M.D. West Coast Retina Medical Group, Inc.
  More Information

Responsible Party: West Coast Retina Medical Group, Inc. ( Jumper, J. Michael, M.D. )
Study ID Numbers: FVF3848s
Study First Received: April 25, 2008
Last Updated: April 28, 2008
ClinicalTrials.gov Identifier: NCT00668785  
Health Authority: United States: Food and Drug Administration

Keywords provided by Jumper, J. Michael, M.D.:
Ranibizumab
Proliferative Diabetic Retinopathy
Macular Edema following Panretinal Photocoagulation
Safety and Efficacy
Intravitreal Injection

Study placed in the following topic categories:
Eye Diseases
Vascular Diseases
Diabetes Mellitus
Edema
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Diabetic Angiopathies
Macular Edema
Signs and Symptoms
Diabetic Retinopathy
Endocrinopathy
Retinal Diseases
Diabetes Complications
Retinal degeneration

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009