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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Poitiers University Hospital
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01823965
First received: March 27, 2013
Last updated: April 3, 2013
Last verified: March 2013
  Purpose

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

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 ]

Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ranibizumab Drug: ranibizumab

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Criteria

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 ClinicalTrials.gov identifier: NCT01823965

Contacts
Contact: michele BOISSONNOT 0549444891 michele.boissonnot@chu-poitiers.fr

Locations
France
Chu de Poitiers Recruiting
Poitiers, France, 86021
Contact: KATIA GOUROU    0549443283    katia.gourou@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01823965     History of Changes
Other Study ID Numbers: LLOMD
Study First Received: March 27, 2013
Last Updated: April 3, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014