Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: injection of 0.5 mg of Intravitreal Ranibizumab

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • New England Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with 3-5 consecutive Avastin injections; These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months.	Drug: injection of 0.5 mg of Intravitreal Ranibizumab; Following the sterile technique, intravitreal injection of anti-VEGF is applied; Other Names: Lucentis
EXPERIMENTAL: Patients with 6 or more consecutive injections of Bevacizumab; Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months.	Drug: injection of 0.5 mg of Intravitreal Ranibizumab; Following the sterile technique, intravitreal injection of anti-VEGF is applied; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: New England Retina Associates
• Investigators: Principal Investigator: Nauman Chaudhry, MD, New England Retina Associates

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ANTICIPATED): June 1, 2012
• Study Completion (ANTICIPATED): July 1, 2012

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (ESTIMATE): December 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 3, 2013
• Last Update Submitted That Met QC Criteria: May 1, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes; bevacizumab; edema; refractory; ranibizumab
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: DME-NERA