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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
J. Michael Jumper, MD, Jumper, J. Michael, M.D.
ClinicalTrials.gov Identifier:
NCT00668785
First received: April 25, 2008
Last updated: January 27, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Macular Edema
Drug: ranibizumab
Drug: Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

Resource links provided by NLM:


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.) [ Time Frame: March 2010 ] [ Designated as safety issue: No ]

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. [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Percentage of patients that maintain pre-PRP visual acuity at the 3 month time point [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Change between baseline and each efficacy outcome assessment in best-corrected ETDRS visual acuity score (e.g. mean visual acuity score) [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Change in the hyperfluorescence of the macula as assessed by 2 readers blinded to the 2 arms of the study. [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Injection-related events including severe uveitis, infectious endophthalmitis, non-infectious endophthalmitis, retinal detachment, and vitreous hemorrhage. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: March 2007
Study Completion Date: March 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
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.
Other Name: Lucentis
Drug: Ranibizumab
Ranibizumab 0.5mg at baseline, then again at 30 days and/or 60 days post PRP per Investigator discretion.
Other Name: Lucentis

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.

  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 (>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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668785

Locations
United States, California
West Coast Retina Medical Group Inc.
San Francisco, California, United States, 94107
Sponsors and Collaborators
Jumper, J. Michael, M.D.
Genentech, Inc.
Investigators
Principal Investigator: J. Michael Jumper, M.D. West Coast Retina Medical Group, Inc.
  More Information

No publications provided

Responsible Party: J. Michael Jumper, MD, Principal Investigator, Jumper, J. Michael, M.D.
ClinicalTrials.gov Identifier: NCT00668785     History of Changes
Other Study ID Numbers: FVF3848s
Study First Received: April 25, 2008
Last Updated: January 27, 2013
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

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014