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

Age Related Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140411
• Other study ID #: CRFB002DCL01
• Status: Completed
• Phase: Phase 4
• Start date: April 25, 2015
• Est. completion date: December 21, 2016

Study information

• Verified date: October 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab Intravitreal injections
Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Locations

Country	Name	City	State
Chile	Novartis Investigative Site	Providencia	Santiago DE Chile

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Chile, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Best Correct Visual Acuity (BCVA)	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	Change From Baseline in Best-corrected Visual Acuity (BCVA) After 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
Secondary	Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)	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
Secondary	Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.		Week 48
Secondary	Number of Participants With Letters Gain / Loss at 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
Secondary	Change in Mean Visual Function Questionnaire (VFQ-25)	"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