Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema (RED-ES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00901186
First received: May 11, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.


Condition Intervention Phase
Diabetic Macular Edema
Visual Impairment
Drug: RFB002
Procedure: Laser photocoagulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.


Secondary Outcome Measures:
  • Percentage of Participants With Improvement in BCVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.

  • Evolution of Mean Change From Baseline in BCVA by Study Visit [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.

  • Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.

  • Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]
    CRT was assessed by Optical Coherence Tomography (OCT).

  • Percentage of CRT Change From Baseline by Study Visit [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]
    CRT was assessed by Optical Coherence Tomography (OCT).


Enrollment: 83
Study Start Date: November 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFB002
RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
Drug: RFB002
0.5 mg
Other Name: Ranibizumab
Active Comparator: Laser photocoagulation
At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
Procedure: Laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diabetes mellitus 1 or 2, HbA1c < 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
  2. Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
  3. Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
  4. Central foveal thickness >250µm (Optical Coherence Tomography).
  5. Diabetes medication stable in the 3 months prior.

Exclusion Criteria:

In the study eye:

  1. Active intraocular inflammation.
  2. Any active infection.
  3. History of uveitis.
  4. Structural damage within 500 microns of the center of the macula.
  5. Neovascularization of the iris.
  6. Uncontrolled glaucoma in either eye (Intraocular Pressure > 24 mmHg).

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901186

Locations
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Almería, Andalucía, Spain, 04009
Novartis Investigative Site
Cadiz, Andalucía, Spain, 11009
Novartis Investigative Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Novartis Investigative Site
Valladolid, Castilla y Leon, Spain, 47011
Novartis Investigative Site
Terrassa, Cataluña, Spain, 08221
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site
Mallorca, Islas Baleares, Spain, 07198
Novartis Investigative Site
La Laguna, Las Palmas de Gran Canaria, Spain, 38320
Novartis Investigative Site
Pamplona, Navarra, Spain, 31080
Novartis Investigative Site
Barakaldo, Pais Vasco, Spain, 48903
Novartis Investigative Site
Barcelona, Spain, 08021
Novartis Investigative Site
Barcelona, Spain, 08025
Novartis Investigative Site
Las Palmas de Gran Canaria, Spain, 35016
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain, 28002
Novartis Investigative Site
Madrid, Spain, 28035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00901186     History of Changes
Other Study ID Numbers: CRFB002DES01, 2009-010825-37
Study First Received: May 11, 2009
Results First Received: May 30, 2014
Last Updated: July 3, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Diabetic Macular Edema
Ranibizumab
Laser Treatment
Visual impairment

Additional relevant MeSH terms:
Edema
Macular Edema
Vision Disorders
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014