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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)

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: January 18, 2013
Last verified: January 2013
History of Changes
  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: Ranibizumab
Procedure: Laser
 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:

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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change Best Corrected Visual Acuity with ranibizumab 0.5 mg vs laser 12-month. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Best Corrected Visual Acuity with ranibizumab (0.5 mg) vs laser 12-month Measure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean Best Corrected Visual Acuity change with ranibizumab (0.5 mg) vs Laser [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • % of patients with Visual Acuity > 73 letters with ranibizumab (0.5 mg) vs Laser. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Time and mean change in central retinal thickness by optical coherence tomography (OCT) with ranibizumab (0.5 mg) vs Laser [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Monitoring and registry of all adverse events, serious adverse events, visual acuity, concomitant medications, ophthalmologic exams (including count of fingers and movement of the hands), intraocular pressure, vital constants and analytical parameters. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 85
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: 1 Drug: Ranibizumab
Active Comparator: 2 Procedure: Laser

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

Locations
Spain
Novartis Investigative Site
Almería, Andalucía, Spain, 04009
Novartis Investigative Site
Cadiz, Andalucía, Spain, 11009
Novartis Investigative Site
Málaga, Andalucía, Spain, 29010
Novartis Investigative Site
Barcelona, Cataluna, Spain, 08025
Novartis Investigative Site
Hospitalet de Llobregat, Cataluña, Spain, 08907
Novartis Investigative Site
Terrassa, Cataluña, Spain, 08221
Novartis Investigative Site
Mallorca, Islas Baleares, Spain, 07198
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de G.C, Spain, 35016
Novartis Investigative Site
Pamplona, Navarra, Spain, 31080
Novartis Investigative Site
Barakaldo, País Vasco, Spain, 48903
Novartis Investigative Site
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Novartis Investigative Site
Barcelona, Spain, 08021
Novartis Investigative Site
Barcelona, Spain, 08025
Novartis Investigative Site
Madrid, Spain, 28002
Novartis Investigative Site
Madrid, Spain, 28035
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Valencia, Spain, 46026
Novartis Investigative Site
Valladolid, Spain, 47011
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
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration
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, Low
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 May 19, 2013