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

Novartis Pharmaceuticals83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema Visual Impairment

Interventions

RFB002DRUG

0.5 mg

Laser photocoagulationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Novartis Investigative Site

Almería, Andalusia, Spain

Novartis Investigative Site

Cadiz, Andalusia, Spain

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 12 months

Secondary Outcomes

Percentage of Participants With Improvement in BCVA

Time frame: 12 months

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

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.

Time frame: 12 months

Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit

CRT was assessed by Optical Coherence Tomography (OCT).

Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.