- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140411
Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Santiago DE Chile
-
Providencia, Santiago DE Chile, Chile, 7510168
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ranibizumab
Ranibizumab treatment
|
Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 4, 8, 12, 24 and 36
|
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.
|
Baseline, week 48
|
Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.
Time Frame: Week 48
|
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.
|
Baseline, Week 52
|
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."
|
Baseline, week 48
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- CRFB002DCL01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinal Vein Occlusion
-
University of TorontoOntario Research FundUnknownCentral Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Central Retinal Artery Occlusion | Branch Retinal Artery OcclusionCanada
-
University of TorontoPfizer; Unity Health Toronto; Canadian Heart Research Centre; Ontario Association... and other collaboratorsUnknownThrombosis | Central Retinal Vein Occlusion | Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Retinal Vein ThrombosisCanada
-
Palo Alto Medical FoundationTerminatedCentral Retinal Vein Occlusion | Branch Retinal Vein OcclusionUnited States
-
Hanscom, Thomas, M.D.Genentech, Inc.CompletedCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionUnited States
-
Tokyo Medical UniversityUnknownCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionJapan
-
Justis EhlersRegeneron PharmaceuticalsCompletedCentral Retinal Vein Occlusion | Diabetic Macular Edema | Retinal Vein Occlusion | Branch Retinal Vein OcclusionUnited States
-
Hoffmann-La RocheChugai PharmaceuticalCompletedCentral Retinal Vein Occlusion | Macular Edema | Hemiretinal Vein OcclusionUnited States, Korea, Republic of, Brazil, Japan, United Kingdom, China, Argentina, Australia, France, Hungary, Italy, Poland, Spain, Singapore, Austria, Czechia, Germany, Hong Kong, Israel, Portugal, Russian Federation, Taiwan
-
The Emmes Company, LLCNational Eye Institute (NEI); University of California, DavisActive, not recruitingCentral Retinal Vein OcclusionUnited States
-
Universitaire Ziekenhuizen KU LeuvenWithdrawn
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenCompleted
Clinical Trials on Ranibizumab Intravitreal injections
-
Hospital Regional de São José - Dr. Homero de Miranda...UnknownDiabetic Retinopathy | Vitreous HemorrhageBrazil
-
Novartis PharmaceuticalsCompleted
-
Dongyang People's HospitalRecruiting
-
Hoffmann-La RocheCompletedNeovascular Age-Related Macular DegenerationUnited States
-
Santen Inc.TerminatedNon Infectious UveitisUnited States, India, Italy, Argentina
-
Peking University People's HospitalCompletedProliferative Diabetic RetinopathyChina
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompleted
-
Hospital St. Joseph, Marseille, FranceUnknownExudative Age-Related Macular DegenerationFrance
-
University Hospital, Basel, SwitzerlandCompletedAge-Related Macular Degeneration | Choroidal NeovascularizationSwitzerland
-
Beijing HospitalCompletedDiabetic Macular EdemaChina