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

This study has been completed.
Information provided by (Responsible Party):
Poitiers University Hospital Identifier:
First received: March 27, 2013
Last updated: March 29, 2016
Last verified: March 2016
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 Intervention Phase
Diabetic Macular Edema Drug: ranibizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Poitiers University Hospital:

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

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

Enrollment: 35
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ranibizumab Drug: ranibizumab


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01823965

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

Responsible Party: Poitiers University Hospital Identifier: NCT01823965     History of Changes
Other Study ID Numbers: LLOMD
Study First Received: March 27, 2013
Last Updated: March 29, 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 processed this record on September 21, 2017