Status:
COMPLETED
High Blood Pressure and Sleep Apnea in Diabetic Macular Edema
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Macular edema remains a major cause of vision impairment in diabetic patients. Its pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a role in this pathogenesis...
Detailed Description
Patients with type 2 diabetes and macular edema involving the center of the macula in both eyes will be randomly assigned to receive conventional treatment in accordance with national guidelines or to...
Eligibility Criteria
Inclusion
- Patient with type 2 diabetes, aged 18 years or more
- Bilateral diabetic macular edema involving the center of the macula with central retinal thickness 300 µm or more
Exclusion
- Patient with type 1 diabetes
- Tractional macular edema
- Patient with renal insufficiency : clearance of creatinin \< 30 ml/min according to COCROFT or MDRD, patient under dialysis
- Other causes for macular edema (uveitis, epiretinal membrane)
- Proliferative diabetic retinopathy requiring panretinal photocoagulation at inclusion
- Cataract surgery or panretinal photocoagulation during the 6 months before inclusion, laser photocoagulation at the posterior pole or intra ocular steroid injection during the 3 months before inclusion
- Any ocular condition precluding access to the posterior pole, or ocular pathologies not related to diabetes (age related macular degeneration venous occlusion…)
- Previous vitrectomy in the eyes
- Pregnant or breast-feeding female
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00970723
Start Date
September 1 2009
End Date
January 1 2014
Last Update
April 14 2014
Active Locations (5)
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1
Service d'ophtalmologie, Hôpital de la Vision, La Timone
Marseille, Bouches du Rhone, France, 13005
2
Service d'Ophtalmologie, Hôtel Dieu
Nantes, Loire Atlantique, France, 44093
3
Service d'Ophtalmologie, Hôpital Avicenne
Bobigny, Île-de-France Region, France, 93009
4
Hôpital Lariboisière, service d'Ophtalmologie
Paris, Île-de-France Region, France, 75010