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

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ClinicalTrials.gov Identifier: NCT00901186
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : July 3, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Visual Impairment Drug: RFB002 Procedure: Laser photocoagulation Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 12 months ]
    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 :
  1. Percentage of Participants With Improvement in BCVA [ Time Frame: 12 months ]
    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.

  2. 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 ]
    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.

  3. Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser. [ Time Frame: 12 months ]
    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.

  4. 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 ]
    CRT was assessed by Optical Coherence Tomography (OCT).

  5. 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 ]
    CRT was assessed by Optical Coherence Tomography (OCT).


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 28002
Novartis Investigative Site
Madrid, Spain, 28035
Novartis Investigative Site
Madrid, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Novartis
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00901186     History of Changes
Other Study ID Numbers: CRFB002DES01
2009-010825-37 ( EudraCT Number )
First Posted: May 13, 2009    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: March 3, 2017
Last Verified: July 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents