Status:
WITHDRAWN
Ranibizumab as a Rescue Therapy for Diabetic Macular Edema
Lead Sponsor:
New England Retina Associates
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Age \> 18 years
- Diagnosis of diabetes mellitus (type 1 or 2)
- Residual edema as determined by mean foveal thickness on Spectralis OCT (optical coherence tomography) \> 300 microns and leakage seen on FA at baseline
- Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
- Previous history of at least 3-5 or more consecutive 1.25 mg of intravitreal bevacizumab injections for the treatment of diabetic macular edema (consecutive injections administered no more than 6 weeks apart).
- BCVA of 20/32-20/400 using Early Treatment Diabetic Retinopathy Study (ETDRS)
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
- Participation in another ocular investigation or trial simultaneously.
- Systemic use of anti-VEGF within 3 months prior to day 0.
- Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110)
- Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).
- Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
- An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis, ischemic maculopathy or geographic atrophy).
- Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. Age-related Macular Degeneration, uveitis, Irvine-Gass).
- Evidence of active neovascularization of the iris or retina.
- Evidence of central atrophy or fibrosis in the study eye.
- Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
- History of vitreous surgery in the study eye.
- History of cataract surgery within 6 months of enrollment.
- History of YAG capsulotomy within 2 months of enrollment.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01253694
Start Date
March 1 2011
End Date
July 1 2012
Last Update
May 3 2013
Active Locations (1)
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1
New England Retina Associates
Norwich, Connecticut, United States, 06360