Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

NCT01253694 | Withdrawn Phase 2 DMC

• 1 other identifier: DME-NERA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Diabetes; edema; ranibizumab; bevacizumab; refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the main change in BCVA (best corrected visual acuity) score over time

  6-12 months

Study Arms (2)

Patients with 3-5 consecutive Avastin injections

EXPERIMENTAL

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

Drug: injection of 0.5 mg of Intravitreal Ranibizumab

Patients with 6 or more consecutive injections of Bevacizumab

EXPERIMENTAL

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

Drug: injection of 0.5 mg of Intravitreal Ranibizumab

Interventions

injection of 0.5 mg of Intravitreal Ranibizumab DRUG

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

Also known as: Lucentis

Patients with 3-5 consecutive Avastin injections; Patients with 6 or more consecutive injections of Bevacizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• New England Retina Associates: lead

Study Sites (1)

New England Retina Associates

Norwich, Connecticut, 06360, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nauman Chaudhry, MD

  New England Retina Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 3, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)