Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01253694
• Other study ID #: DME-NERA
• Status: Withdrawn
• Phase: Phase 2
• First received: November 30, 2010
• Last updated: May 1, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: New England Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• injection of 0.5 mg of Intravitreal Ranibizumab
Following the sterile technique, intravitreal injection of anti-VEGF is applied

Locations

Country	Name	City	State
United States	New England Retina Associates	Norwich	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
New England Retina Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns.		6 months	No
Secondary	Evaluate the main change in BCVA (best corrected visual acuity) score over time	They will evaluate the amount of patients gaining 3 or more letters and the amount of patients losing 3 or more letters.	6-12 months	Yes