Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01823965
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: ranibizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ranibizumab Drug: ranibizumab

Primary Outcome Measures :
  1. Number of intravitreal injections of ranibizumab [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. best-corrected visual acuity [ Time Frame: 1 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01823965

Chu de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

Responsible Party: Poitiers University Hospital Identifier: NCT01823965     History of Changes
Other Study ID Numbers: LLOMD
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents