Ranibizumab as a Rescue Therapy for Diabetic Macular Edema
Phase 2
Withdrawn
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: injection of 0.5 mg of Intravitreal Ranibizumab
- Registration Number
- NCT01253694
- Lead Sponsor
- New England Retina Associates
- Brief Summary
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with 6 or more consecutive injections of Bevacizumab injection of 0.5 mg of Intravitreal Ranibizumab Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months. Patients with 3-5 consecutive Avastin injections injection of 0.5 mg of Intravitreal Ranibizumab These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months.
- Primary Outcome Measures
Name Time Method Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns. 6 months
- Secondary Outcome Measures
Name Time Method Evaluate the main change in BCVA (best corrected visual acuity) score over time 6-12 months They will evaluate the amount of patients gaining 3 or more letters and the amount of patients losing 3 or more letters.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Ranibizumab's efficacy in residual diabetic macular edema after Bevacizumab failure?
How does Ranibizumab compare to standard-of-care therapies for diabetic macular edema in phase 2 trials?
Which biomarkers correlate with response to anti-VEGF therapies like Ranibizumab in diabetic retinopathy patients?
What are the potential adverse events associated with intravitreal Ranibizumab in patients previously treated with Bevacizumab?
How do combination therapies involving Ranibizumab and corticosteroids impact treatment-resistant diabetic macular edema outcomes?
Trial Locations
- Locations (1)
New England Retina Associates
🇺🇸Norwich, Connecticut, United States
New England Retina Associates🇺🇸Norwich, Connecticut, United States