NCT01297569

Brief Summary

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 15, 2011

Last Update Submit

February 20, 2017

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edemaMacular edemaDMEDiabetic retinopathyDiabetic eye diseaseanti-VEGFranibizumabLucentis

Outcome Measures

Primary Outcomes (1)

  • Change in Best Corrected Visual Acuity(BCVA)

    from month 0 (baseline) to month 12

Secondary Outcomes (4)

  • change in central retinal thickness (CRT)

    from month 0 to month 12

  • the number of injections needed

    12 months

  • the number of patients with improvement in BCVA from baseline

    12 months

  • the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84

    12 months

Study Arms (1)

Ranibizumab

EXPERIMENTAL
Drug: Ranibizumab

Interventions

RanibizumabDRUG
Ranibizumab

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Visual impairment due to focal or diffuse macular edema with center involvement
  • Diabetes type 1 or 2, HbA1c \< 12.0%
  • CRT = or \> 250 μm

You may not qualify if:

  • Active inflammation or infection
  • Uncontrolled glaucoma
  • Iris neovascularization, active proliferative retinopathy or vitreomacular traction
  • Prior laser photocoagulation according to defined timelines
  • History of stroke, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Oslo, 0264, Norway

Location

MeSH Terms

Conditions

Macular EdemaDiabetic Retinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

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

February 15, 2011

First Posted

February 16, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

NO(1)