Overview

This trial is active, not recruiting.

Condition efficacy and safety of ranibizumab (lucentis)
Treatment lucentis intravitreal injections
Phase phase 4
Sponsor Novartis Pharmaceuticals
Start date April 2015
End date January 2017
Trial size 21 participants
Trial identifier NCT02140411, CRFB002DCL01

Summary

Lucentis® (ranibizumab) is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration.

Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lucentis treatment
lucentis intravitreal injections
Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Primary Outcomes

Measure
Mean Change from baseline in Best Correct Visual Acuity (BCVA)
time frame: 48 weeks

Secondary Outcomes

Measure
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) composite score
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or fluorescein angiography, and/or OCT) in at least one eye. 2. Vision impairment due to DME (BCVA ETDRS letter score at 4 meters between 20 and 70 letters (6/12 - 3/60 at Snellen chart). Exclusion Criteria: -1. Laser photocoagulation in the study eye for the last 3 months. 2. Any history of any intraocular surgery in the study eye within the past 3 months. 3. Blood pressure >160/100 mmHg. 4. Proliferative Diabetic Retinopathy. Any other protocol inclusion/exclusion criteria that may apply.

Additional Information

Official title Chilean Interventional Open Label Pilot Study, to Assess the Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Novartis.