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WithdrawnNCT01253694Updated May 3, 2013

Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

A Phase 2 interventional study of injection of 0.5 mg of Intravitreal Ranibizumab in Diabetic Macular Edema, sponsored by New England Retina Associates. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by New England Retina Associates · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Macular Edema

Keywords

  • Diabetes
  • edema
  • ranibizumab
  • bevacizumab
  • refractory
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

Browse Macular Edema studies →

Lead sponsor

New England Retina Associates is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Druginjection of 0.5 mg of Intravitreal Ranibizumab

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

    Also known as: Lucentis

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6-12 months

07

Study locations

1 site
  • New England Retina Associates
    Norwich, Connecticut 06360, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01253694
Lead sponsor
New England Retina Associates
Responsible party
Sponsor
First posted
Dec 3, 2010
Start date
Mar 2011
Primary completion
Jun 2012 (estimated)
Completion
Jul 2012 (estimated)
Last update
May 3, 2013

Study contacts

Nauman Chaudhry, MD
principal investigator · New England Retina Associates

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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