NCT02140411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

April 25, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 20, 2019

Completed
Last Updated

February 20, 2019

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

May 14, 2014

Results QC Date

February 7, 2018

Last Update Submit

October 10, 2018

Conditions

Retinal Vein OcclusionAge Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36

    Baseline, Week 4, 8, 12, 24 and 36

  • Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)

    Baseline, week 48

  • Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.

    Week 48

  • Number of Participants With Letters Gain / Loss at Week 52

    Baseline, Week 52

  • Change in Mean Visual Function Questionnaire (VFQ-25)

    Baseline, week 48

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Ranibizumab treatment

Drug: Ranibizumab Intravitreal injections

Interventions

Ranibizumab Intravitreal injectionsDRUG

Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Ranibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Providencia, Santiago de Chile, 7510168, Chile

Location

Related Publications (2)

  • 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.

    PMID: 15111519BACKGROUND

  • 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.

    PMID: 12941734RESULT

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Degeneration

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesRetinal Degeneration

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-1873

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

April 25, 2015

Primary Completion

December 21, 2016

Study Completion

December 21, 2016

Last Updated

February 20, 2019

Results First Posted

February 20, 2019

Record last verified: 2018-10

Locations

CL(1)