Status:
COMPLETED
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 E...
Detailed Description
Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from...
Eligibility Criteria
Inclusion
- SUBJECT-LEVEL INCLUSION CRITERIA
- To be eligible, the following inclusion criteria (1-3) must be met:
- Age \>= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Able and willing to provide informed consent.
- EXCLUSION
- A subject is not eligible if any of the following exclusion criteria (4-13) are present:
- 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
- The subject must have one eye meeting all of the inclusion criteria (a-e) and none of the exclusion criteria (f-r) listed below.
- 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:
- INCLUSION
- 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.
- OCT central subfield \>=275 microns within 8 days of randomization.
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
- If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional photocoagulation.
- EXCLUSION
- The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of treatment for DME at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- History of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization.
- Anticipated need for PRP in the 6 months following randomization.
- History of prior pars plana vitrectomy.
- History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 6 months or anticipated within the next 6 months following randomization.
- History of YAG capsulotomy performed within 2 months prior to randomization.
- Aphakia.
- Uncontrolled glaucoma (in investigator's judgment).
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
- FELLOW EYE CRITERIA
- The fellow eye must meet the following criteria:
- Best corrected E-ETDRS visual acuity letter score \>= 19 (i.e., 20/400 or better).
- No anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 3 months.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00336323
Start Date
June 1 2006
End Date
February 1 2008
Last Update
August 26 2016
Active Locations (34)
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1
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States, 92354
2
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262
3
California Retina Consultants
Santa Barbara, California, United States, 93103
4
Bay Area Retina Associates
Walnut Creek, California, United States, 94598