Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

New England Retina Associates

Status and phase: Withdrawn; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: injection of 0.5 mg of Intravitreal Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01253694

DME-NERA

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Patients with 3-5 consecutive Avastin injections

Experimental group

Description:

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

Treatment:

Drug: injection of 0.5 mg of Intravitreal Ranibizumab

Patients with 6 or more consecutive injections of Bevacizumab

Experimental group

Description:

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

Treatment:

Drug: injection of 0.5 mg of Intravitreal Ranibizumab