A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
Bevacizumab
5 other identifiers
interventional
121
1 country
34
Brief Summary
This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial. In addition, this study will provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
July 12, 2011
CompletedAugust 26, 2016
August 1, 2016
5 months
June 9, 2006
March 16, 2011
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits
Change in central subfield retinal thickness from baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading. Negative changes represent a decrease in retinal thickening.
Baseline to 3,6,9, and 12 weeks
Percentage of Participants With <250 Microns or ≥ 50% Reduction in Retinal Thickening From Baseline Over All Study Visits
Central subfield retinal thickness measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading.
Baseline to 3,6,9, and 12 Weeks
Secondary Outcomes (2)
Change in Visual Acuity Letter Score From Baseline Over All All Study Visits
Baseline to 3,6,9, and 12 weeks
Distribution of Change in Visual Acuity Over All Study Visits
Baseline to 3,6,9, and 12 weeks
Other Outcomes (28)
Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Central Subfield Thickness
Baseline to 3 Weeks
Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Visual Acuity Letter Score
Baseline to 3 Weeks
Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline
Baseline to 3 Weeks
- +25 more other outcomes
Study Arms (5)
1
ACTIVE COMPARATORLaser photocoagulation at baseline
2
EXPERIMENTAL1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
3
EXPERIMENTAL2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
4
EXPERIMENTAL1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
5
EXPERIMENTAL1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
Interventions
Laser photocoagulation at baseline; If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Able and willing to provide informed consent.
You may not qualify if:
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drug.
- Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 6 months.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 6 months of the study.
- STUDY EYE CRITERIA
- Subjects can have only one study eye. If both eyes are eligible, the study eye will be selected by the investigator and subject.
- The eligibility criteria for a study eye are as follows:
- Best corrected E-ETDRS visual acuity letter score of \>= 24 (i.e., 20/320 or better) and \<= 78 (i.e., 20/32 or worse) within 8 days of randomization.
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
Study Sites (34)
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354, United States
Southern California Desert Retina Consultants, MC
Palm Springs, California, 92262, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retina Vitreous Consultants
Fort Lauderdale, Florida, 33334, United States
Central Florida Retina Institute
Lakeland, Florida, 33805, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
Illinois Retina Associates
Joliet, Illinois, 60435, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46280, United States
American Eye Institute
New Albany, Indiana, 47150, United States
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Maine Vitreoretinal Consultants
Bangor, Maine, 04401, United States
Elman Retina Group, P.A.
Baltimore, Maryland, 21237, United States
Retina Consultants of Delmarva, P.A.
Salisbury, Maryland, 21801, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Retina Center, PA
Minneapolis, Minnesota, 55404, United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina, 28210, United States
Wake Forest University Eye Center
Winston-Salem, North Carolina, 27157, United States
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, 44122, United States
Retina Northwest, PC
Portland, Oregon, 97210, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
Retina Consultants
Providence, Rhode Island, 02903, United States
Palmetto Retina Center
Columbia, South Carolina, 29169, United States
Carolina Retina Center
Columbia, South Carolina, 29223, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, 37909, United States
West Texas Retina Consultants P.A.
Abilene, Texas, 79605, United States
Retina Research Center
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Charles A. Garcia, PA & Associates
Houston, Texas, 77002, United States
Texas Retina Associates
Lubbock, Texas, 79424, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (3)
Diabetic Retinopathy Clinical Research Network; Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR. A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology. 2007 Oct;114(10):1860-7. doi: 10.1016/j.ophtha.2007.05.062. Epub 2007 Aug 15.
PMID: 17698196RESULTScott IU, Bressler NM, Bressler SB, Browning DJ, Chan CK, Danis RP, Davis MD, Kollman C, Qin H; Diabetic Retinopathy Clinical Research Network Study Group. Agreement between clinician and reading center gradings of diabetic retinopathy severity level at baseline in a phase 2 study of intravitreal bevacizumab for diabetic macular edema. Retina. 2008 Jan;28(1):36-40. doi: 10.1097/IAE.0b013e31815e9385.
PMID: 18185135RESULTBhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.
PMID: 17765429DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Name/Official Title: Adam Glassman, M.S., Director
- Organization
- Jaeb Center for Health Research, Diabetic Retinopathy Clinical Research Network
Study Officials
- STUDY CHAIR
Ingrid U. Scott, M.D., M.P.H.
Penn State College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2006
First Posted
June 13, 2006
Study Start
June 1, 2006
Primary Completion
November 1, 2006
Study Completion
February 1, 2008
Last Updated
August 26, 2016
Results First Posted
July 12, 2011
Record last verified: 2016-08