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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-25

Study Completion Date

2016-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Retinal Vein Occlusion Age Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab

Ranibizumab treatment

Group Type EXPERIMENTAL

Ranibizumab Intravitreal injections

Intervention Type DRUG

Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Interventions

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Ranibizumab Intravitreal injections

Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No