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OpenTrials
Completed

NCT Number: NCT00901186

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

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.

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Key information

Conditions

Diabetic Macular Edema Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Almería, Andalusia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

In the study eye:

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

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

RFB002

Drug

0.5 mg

Other names: Ranibizumab

Laser Photocoagulation

Procedure

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: RED-ES

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 13, 2009
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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