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Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
New England Retina Associates
ClinicalTrials.gov Identifier:
NCT01253694
First received: November 30, 2010
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetic Macular Edema
 Drug: injection of 0.5 mg of Intravitreal Ranibizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by New England Retina Associates:

Primary Outcome Measures:
  • Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the main change in BCVA (best corrected visual acuity) score over time [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
    They will evaluate the amount of patients gaining 3 or more letters and the amount of patients losing 3 or more letters.


Enrollment: 0
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253694

Locations
United States, Connecticut
New England Retina Associates
Norwich, Connecticut, United States, 06360
Sponsors and Collaborators
New England Retina Associates
Investigators
Principal Investigator: Nauman Chaudhry, MD New England Retina Associates
  More Information

No publications provided

Responsible Party: New England Retina Associates
ClinicalTrials.gov Identifier: NCT01253694     History of Changes
Other Study ID Numbers: DME-NERA
Study First Received: November 30, 2010
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New England Retina Associates:
Diabetes
edema
ranibizumab
bevacizumab
refractory

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013