search
Back to results

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

Primary Purpose

Diabetic Macular Edema, Visual Impairment

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
RFB002
Laser photocoagulation
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, Ranibizumab, Laser Treatment, Visual impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RFB002

Laser photocoagulation

Arm Description

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.

At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
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
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
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.
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
CRT was assessed by Optical Coherence Tomography (OCT).
Percentage of CRT Change From Baseline by Study Visit
CRT was assessed by Optical Coherence Tomography (OCT).

Full Information

First Posted
May 11, 2009
Last Updated
February 28, 2017
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00901186
Brief Title
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
Acronym
RED-ES
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Visual Impairment
Keywords
Diabetic Macular Edema, Ranibizumab, Laser Treatment, Visual impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFB002
Arm Type
Experimental
Arm Description
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.
Arm Title
Laser photocoagulation
Arm Type
Active Comparator
Arm Description
At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
Intervention Type
Drug
Intervention Name(s)
RFB002
Other Intervention Name(s)
Ranibizumab
Intervention Description
0.5 mg
Intervention Type
Procedure
Intervention Name(s)
Laser photocoagulation
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
Description
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.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Improvement in BCVA
Description
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.
Time Frame
12 months
Title
Evolution of Mean Change From Baseline in BCVA by Study Visit
Description
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.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.
Description
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.
Time Frame
12 months
Title
Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit
Description
CRT was assessed by Optical Coherence Tomography (OCT).
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Percentage of CRT Change From Baseline by Study Visit
Description
CRT was assessed by Optical Coherence Tomography (OCT).
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Almería
State/Province
Andalucía
ZIP/Postal Code
04009
Country
Spain
Facility Name
Novartis Investigative Site
City
Cadiz
State/Province
Andalucía
ZIP/Postal Code
11009
Country
Spain
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novartis Investigative Site
City
Terrassa
State/Province
Cataluña
ZIP/Postal Code
08221
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Novartis Investigative Site
City
La Laguna
State/Province
Las Palmas de Gran Canaria
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31080
Country
Spain
Facility Name
Novartis Investigative Site
City
Barakaldo
State/Province
Pais Vasco
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novartis Investigative Site
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs