Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy

NCT01472510 | Completed Phase 2 DMC

• 1 other identifier: ML27906
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME).

Conditions

Diabetic Macular Edema

Keywords

Diabetic; Macular; Edema; Ranibizumab; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Change in Visual Acuity Scores at Month 12 Compared to Baseline

  12 months

Secondary Outcomes (1)

• Resolution of residual edema compared to baseline as determined by mean foveal thickness on Cirrus OCT 300 microns at Month 6 and Month 12.

  12 months

Study Arms (2)

Arm 1:The PRN Group

ACTIVE COMPARATOR

You will receive 6 monthly intravitreal injections of 0.5% Ranibizumab administered about every 28 days. It is possible you may receive additional injections into the study eye for the next six months if certain criteria is met.

Drug: Ranibizumab

arm 2:The Monthly Group:

ACTIVE COMPARATOR

You will receive 12 monthly intravitreal injections of 0.5% Ranibizumab administered every 28 days.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection

Also known as: lucentis

Arm 1:The PRN Group

Eligibility Criteria

• Age: 18 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 Cirrus OCT \> 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 4 or more consecutive anti-VEGF intravitreal injections of Pegaptanib sodium or Bevacizumab (consecutive injections administered no more than 6 weeks apart in the last year) for the treatment of diabetic macular edema.
• Previous history of focal laser and/or intravitreal steroid injection for the treatment of diabetic macular edema.
• BCVA of 20/32-20/400 (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. . The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Participation in another ocular investigation or trial simultaneously.
• Systemic use of anti-VEGF within 3 months prior to day 0.
• Previous intravitreal ranibizumab 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. AMD, 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

• Vitreo-Retinal Associates, PC: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

• Frank J McCabe, M.D.

  Vitreo-Retinal Associates, PC

  PRINCIPAL INVESTIGATOR

• Marie V Lampson

  Vitreo-Retinal Associates, PC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 16, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

US (1)