Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.

Phase 4

Completed

Conditions: Retinal Vein Occlusion
Age Related Macular Degeneration

Interventions: Drug: Ranibizumab Intravitreal injections

Registration Number: NCT02140411

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

Inclusion Criteria

Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or fluorescein angiography, and/or OCT) in at least one eye.
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

Laser photocoagulation in the study eye for the last 3 months.
Any history of any intraocular surgery in the study eye within the past 3 months.
Blood pressure >160/100 mmHg.
Proliferative Diabetic Retinopathy.

Any other protocol inclusion/exclusion criteria that may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab Intravitreal injections	Ranibizumab treatment

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Correct Visual Acuity (BCVA)	baseline, week 48	Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36	Baseline, Week 4, 8, 12, 24 and 36	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)	Baseline, week 48	Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.	Week 48
Number of Participants With Letters Gain / Loss at Week 52	Baseline, Week 52	Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Change in Mean Visual Function Questionnaire (VFQ-25)	Baseline, week 48	"Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening."