NCT01823965

Brief Summary

In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 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

October 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

March 27, 2013

Last Update Submit

March 29, 2016

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Number of intravitreal injections of ranibizumab

    1 years

Secondary Outcomes (1)

  • best-corrected visual acuity

    1 years

Study Arms (1)

ranibizumab

EXPERIMENTAL
Drug: ranibizumab

Interventions

ranibizumabDRUG
ranibizumab

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus (1 or2)
  • decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity\<69 letters using E.T.D.R.S testing)
  • macular edema

You may not qualify if:

  • history of severe cardiac disease
  • stroke within 12 months
  • intraocular inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 4, 2013

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

FR(1)