Phase 4
Completed N=21
Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
Source: ClinicalTrials.gov NCT02140411 ↗Enrolled (actual)
21
Serious AEs
28.6%
Results posted
Feb 2019
Primary outcomePrimary: Mean Change From Baseline in Best Correct Visual Acuity (BCVA) — 9.55 Letters
◆ Published Evidence
Highly cited
842citations · ~37 / year
Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies.
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.
Linked Publications
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Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Correct Visual Acuity (BCVA) |
9.55 | — |
| SECONDARY Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 |
5.65; 6.90; 8.50; 8.05; 8.40 | — |
| SECONDARY Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT) |
388.50; 367.06 | — |
| SECONDARY Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period. |
7 | — |
| SECONDARY Number of Participants With Letters Gain / Loss at Week 52 |
14; 8; 5; 0; 0; 0 | — |
| SECONDARY Change in Mean Visual Function Questionnaire (VFQ-25) |
12.50; 13; 11.88; 7.50; 9.62; 13.13 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02140411) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.