NCT01131585

Brief Summary

This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

34 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

May 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 17, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

May 25, 2010

Results QC Date

July 12, 2012

Last Update Submit

August 20, 2012

Conditions

Visual Impairment Due to Diabetic Macular Edema

Keywords

Diabetic macular edemaDMEProliferative diabetic retinopathyPDRranibizumablaser

Outcome Measures

Primary Outcomes (1)

  • Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12

    Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.

    12 months

Study Arms (2)

Active laser photocoagulation and ranibizumab

EXPERIMENTAL

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Procedure: Active laser photocoagulationDrug: Ranibizumab 0.5 mg

Active laser photocoagulation and sham injection

ACTIVE COMPARATOR

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Procedure: Active laser photocoagulationDrug: Sham injections

Interventions

Active laser photocoagulationPROCEDURE

Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Active laser photocoagulation and ranibizumabActive laser photocoagulation and sham injection
Sham injectionsDRUG

Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Active laser photocoagulation and sham injection
Ranibizumab 0.5 mgDRUG

Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Active laser photocoagulation and ranibizumab

Eligibility Criteria

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

You may qualify if:

  • Visual acuity impairment caused by macular edema in at least one eye
  • Type 1 or type 2 diabetes mellitus
  • Stable medication of diabetes in past 3 month

You may not qualify if:

  • Patients with uncontrolled systemic or ocular diseases
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Novartis Investigative Site

Aschaffenburg, Germany

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Bonn, Germany

Location

Novartis Investigative Site

Bremen, Germany

Location

Novartis Investigative Site

Chemnitz, Germany

Location

Novartis Investigative Site

Cologne, Germany

Location

Novartis Investigative Site

Darmstadt, Germany

Location

Novartis Investigative Site

Dessau, Germany

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Novartis Investigative Site

Dortmund, Germany

Location

Novartis Investigative Site

Dresden, Germany

Location

Novartis Investigative Site

Eichstätt, Germany

Location

Novartis Investigative Site

Essen, Germany

Location

Novartis Investigative Site

Frankfurt, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, Germany

Location

Novartis Investigative Site

Giessen, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Novartis Investigative Site

Heidelberg, Germany

Location

Novartis Investigative Site

Karlsruhe, Germany

Location

Novartis Investigative Site

Kiel, Germany

Location

Novartis Investigative Site

Landshut, Germany

Location

Novartis Investigative Site

Leipzig, Germany

Location

Novartis Investigative Site

Marburg, Germany

Location

Novartis Investigative Site

Mühlheim, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Münster, Germany

Location

Novartis Investigative Site

Nuremberg, Germany

Location

Novartis Investigative Site

Postdam, Germany

Location

Novartis Investigative Site

Recklinghausen, Germany

Location

Novartis Investigative Site

Regensburg, Germany

Location

Novartis Investigative Site

Rosenheim, Germany

Location

Novartis Investigative Site

Siegburg, Germany

Location

Novartis Investigative Site

Stuttgart, Germany

Location

Novartis Investigative Site

Ulm, Germany

Location

Novartis Investigative Site

Würzburg, Germany

Location

Related Links

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Early study termination due to European drug approval.

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
41 61 324 1111

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 27, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 30, 2012

Results First Posted

August 17, 2012

Record last verified: 2012-08

Locations

DE(34)