NCT02032173

Brief Summary

The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
terminated

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

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 19, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2015

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

January 8, 2014

Results QC Date

March 10, 2016

Last Update Submit

September 29, 2020

Conditions

Macular EdemaMacular DegenerationDiabetes

Keywords

RanibizumabDiabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months

    Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) were reported.

    Month 6 and 24

Secondary Outcomes (9)

  • Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 11 Months

    Month 11 and 24

  • Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 Letters

    Baseline, Month 3, 6, 8 and 11

  • Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 Letters

    Baseline, Months 3, 6, 8 and 11

  • Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye.

    Months 6, 8 and 11

  • Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS)

    Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11

  • +4 more secondary outcomes

Study Arms (1)

Ranibizumab 0.5mg

EXPERIMENTAL

Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Drug: Ranibizumab 0.5mg

Interventions

Ranibizumab 0.5mgDRUG

Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Ranibizumab 0.5mg

Eligibility Criteria

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

You may qualify if:

  • Type I or type II diabetes with HbA1c≤10%
  • Visual impairment due to a diabetic macular edema
  • Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary

You may not qualify if:

  • Inflammation or infection in one eye
  • Women of childbearing potential without an efficient contraception, pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Bobigny, Seine Saint Denis, 93009, France

Location

Novartis Investigative Site

Bordeaux, 33000, France

Location

Novartis Investigative Site

Bordeaux, F-33076, France

Location

Novartis Investigative Site

Créteil, 94000, France

Location

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France

Location

Novartis Investigative Site

Lyon, 69002, France

Location

Novartis Investigative Site

Nice, 06000, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Paris, 75940, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Macular EdemaMacular DegenerationDiabetes Mellitus

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

May 19, 2014

Primary Completion

April 29, 2015

Study Completion

April 29, 2015

Last Updated

October 22, 2020

Results First Posted

October 22, 2020

Record last verified: 2020-09

Locations

FR(10)