NCT02366468

Brief Summary

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

30 active sites

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

January 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

February 23, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 4, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

January 12, 2015

Results QC Date

June 5, 2018

Last Update Submit

January 1, 2019

Conditions

Diabetic Retinopathy

Keywords

Diabetic macular edemaVisual impairment

Outcome Measures

Primary Outcomes (1)

  • Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)

    BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity

    Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Secondary Outcomes (6)

  • Number of Visits

    Baseline to Month 12

  • Number of Injections

    Baseline to Month 12

  • Number of Treatment Free Intervals

    Baseline to Month 12

  • Mean Change in Central Subfield Retinal Thickness (CSRT)

    Baseline to Month 12

  • Mean Change of Foveal Center Point Thickness

    Baseline to Month 12

  • +1 more secondary outcomes

Study Arms (2)

Discretion of the investigator (DI)

EXPERIMENTAL

ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.

Drug: ranibizumab 0.5 mg

Pro re nata (PRN)

ACTIVE COMPARATOR

ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred

Drug: ranibizumab 0.5 mg

Interventions

ranibizumab 0.5 mgDRUG

intravitreal injection

Also known as: Lucentis
Discretion of the investigator (DI)Pro re nata (PRN)

Eligibility Criteria

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

You may qualify if:

  • Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
  • Patients with visual impairment due to DME in at least one eye
  • BCVA ≥ 24 and ≤ 78 letters in the study eye

You may not qualify if:

  • Active intraocular inflammation
  • Any active infection in either eye at the
  • Structural damage within 0.5 disc diameter of the center of the macula in the study eye
  • Uncontrolled glaucoma in either eye at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Novartis Investigative Site

Ahaus, 48683, Germany

Location

Novartis Investigative Site

Bayreuth, 95444, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Berlin, 14169, Germany

Location

Novartis Investigative Site

Bonn, 53127, Germany

Location

Novartis Investigative Site

Cologne, 50924, Germany

Location

Novartis Investigative Site

Cologne, 50935, Germany

Location

Novartis Investigative Site

Dresden, 01067, Germany

Location

Novartis Investigative Site

Düsseldorf, 40212, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Freiburg I. Br, 79106, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Greifswald, 17475, Germany

Location

Novartis Investigative Site

Halle, 06114, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hösbach, 63768, Germany

Location

Novartis Investigative Site

Kempten, 87435, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67063, Germany

Location

Novartis Investigative Site

Lübeck, 23538, Germany

Location

Novartis Investigative Site

Magdeburg, 39108, Germany

Location

Novartis Investigative Site

Marburg, 35043, Germany

Location

Novartis Investigative Site

München, 80333, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Stuttgart, 70174, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Ulm, 89075, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Diabetic RetinopathyVision Disorders

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

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
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

February 19, 2015

Study Start

February 23, 2015

Primary Completion

June 8, 2017

Study Completion

June 8, 2017

Last Updated

January 4, 2019

Results First Posted

January 4, 2019

Record last verified: 2019-01

Locations

DE(30)