Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

NCT ID: NCT01253694

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-07-31

Brief Summary

Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with 3-5 consecutive Avastin injections

These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months.

Group Type: EXPERIMENTAL

injection of 0.5 mg of Intravitreal Ranibizumab

Intervention Type: DRUG

Following the sterile technique, intravitreal injection of anti-VEGF is applied

Patients with 6 or more consecutive injections of Bevacizumab

Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months.

Group Type: EXPERIMENTAL

injection of 0.5 mg of Intravitreal Ranibizumab

Intervention Type: DRUG

Following the sterile technique, intravitreal injection of anti-VEGF is applied

Interventions

injection of 0.5 mg of Intravitreal Ranibizumab

Following the sterile technique, intravitreal injection of anti-VEGF is applied

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New England Retina Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nauman Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

New England Retina Associates

Locations

New England Retina Associates

Norwich, Connecticut, United States

Countries

United States

Other Identifiers

DME-NERA

Identifier Type: -

Identifier Source: org_study_id