Clinical trial NCT02140411: Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Vein Occlusion
Age Related Macular Degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Any other protocol inclusion/exclusion criteria that may apply.

Primary outcomes:
measure: Mean Change From Baseline in Best Correct Visual Acuity (BCVA)
timeFrame: baseline, week 48
Secondary outcomes:
measure: Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
timeFrame: Baseline, Week 4, 8, 12, 24 and 36
measure: Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)
timeFrame: Baseline, week 48
measure: Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.
timeFrame: Week 48
measure: Number of Participants With Letters Gain / Loss at Week 52
timeFrame: Baseline, Week 52
measure: Change in Mean Visual Function Questionnaire (VFQ-25)
timeFrame: Baseline, week 48
Other outcomes:
Locations:
city: Providencia
country: Chile
facility: Novartis Investigative Site
state: Santiago DE Chile
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
citation: Ciulla TA, Amador AG, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care. 2003 Sep;26(9):2653-64. doi: 10.2337/diacare.26.9.2653.