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Withdrawn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

Study Timeline

• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Study Start: 2011-03
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-01
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects will be eligible if the following criteria are met:

1. Age > 18 years
2. Diagnosis of diabetes mellitus (type 1 or 2)
3. Residual edema as determined by mean foveal thickness on Spectralis OCT (optical coherence tomography) > 300 microns and leakage seen on FA at baseline
4. Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
5. 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).
6. BCVA of 20/32-20/400 using Early Treatment Diabetic Retinopathy Study (ETDRS)
7. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria

1. Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
2. Participation in another ocular investigation or trial simultaneously.
3. Systemic use of anti-VEGF within 3 months prior to day 0.
4. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
5. Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).
6. Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
7. 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).
8. 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).
9. Evidence of active neovascularization of the iris or retina.
10. Evidence of central atrophy or fibrosis in the study eye.
11. Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
12. History of vitreous surgery in the study eye.
13. History of cataract surgery within 6 months of enrollment.
14. 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.

Trial Locations

Locations (1)

New England Retina Associates; 🇺🇸 Norwich, Connecticut, United States