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

Diabetic Macular Edema Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901186
• Other study ID #: CRFB002DES01
• Secondary ID: 2009-010825-37
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2009
• Last updated: February 28, 2017
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: July 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema
• Vision Disorders
• Visual Impairment

Intervention

Drug:
• RFB002
0.5 mg

Procedure:
• Laser photocoagulation

Locations

Country	Name	City	State
Spain	Novartis Investigative Site	Almería	Andalucía
Spain	Novartis Investigative Site	Barakaldo	Pais Vasco
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cadiz	Andalucía
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	La Laguna	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Terrassa	Cataluña
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla y Leon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 months
Secondary	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.	12 months
Secondary	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary	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.	12 months
Secondary	Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit	CRT was assessed by Optical Coherence Tomography (OCT).	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary	Percentage of CRT Change From Baseline by Study Visit	CRT was assessed by Optical Coherence Tomography (OCT).	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12