Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
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|ClinicalTrials.gov Identifier: NCT02140411|
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion Age Related Macular Degeneration||Drug: Ranibizumab Intravitreal injections||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||April 25, 2015|
|Actual Primary Completion Date :||December 21, 2016|
|Actual Study Completion Date :||December 21, 2016|
Drug: Ranibizumab Intravitreal injections
Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.
- Mean Change From Baseline in Best Correct Visual Acuity (BCVA) [ Time Frame: 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.
- Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: Week 48 ]
- Number of Participants With Letters Gain / Loss at Week 52 [ Time Frame: 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) [ Time Frame: 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."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140411
|Novartis Investigative Site|
|Providencia, Santiago DE Chile, Chile, 7510168|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|