Phase 4 N=21 Treatment

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

Retinal Vein Occlusion · Age Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02140411 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Feb 2019

Primary outcome: Primary: Mean Change From Baseline in Best Correct Visual Acuity (BCVA) — 9.55 Letters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ranibizumab Intravitreal injections (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Dec 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02140411). 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.