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

Phase 2

Completed

• Conditions: Diabetic Macular Edema; Visual Impairment
• Interventions: Drug: RFB002; Procedure: Laser photocoagulation

• Registration Number: NCT00901186
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Study Start: 2009-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2014-05-30
• Results First Submitted QC: 2014-05-30
• Status Verified: 2014-07
• Results First Posted: 2014-07-03
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFB002	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.
Laser photocoagulation	Laser photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)	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

Name	Time	Method
Percentage of Participants With Improvement in BCVA	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.
Evolution of Mean Change From Baseline in BCVA by Study Visit	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.
Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.	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.
Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	CRT was assessed by Optical Coherence Tomography (OCT).
Percentage of CRT Change From Baseline by Study Visit	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	CRT was assessed by Optical Coherence Tomography (OCT).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Madrid, Spain