High Blood Pressure and Sleep Apnea in Diabetic Macular Edema

Not Applicable

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Behavioral: high blood pressure treatment; Behavioral: sleep apnea treatment; Behavioral: diabetic macular edema treatment

• Registration Number: NCT00970723
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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, including high blood pressure. The objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.

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 receive intensive treatment, with a systematic screening for sleep apnea and /or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected. The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year. Secondary outcomes will be the percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year, number of ocular interventions in each group, prevalence of sleep apnea and uncontrolled high blood pressure in the intervention group.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intensive treatment	high blood pressure treatment	with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected
intensive treatment	sleep apnea treatment	with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected
intensive treatment	diabetic macular edema treatment	with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected
conventional treatment	diabetic macular edema treatment	in accordance with national guidelines

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year, assessed with OCT in the study eye.	M13

Secondary Outcome Measures

Name	Time	Method
Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye	M13
Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye	M6-9
Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye	M13
Comparison of blood pressure in each group at one year	M13

Trial Locations

Locations (5)

Service d'ophtalmologie, Hôpital de la Vision, La Timone; 🇫🇷 Marseille, Bouches du Rhone, France

Service d'Ophtalmologie, Hôpital Avicenne; 🇫🇷 Bobigny, Ile de france, France

Service d'Ophtalmologie, Hôtel Dieu; 🇫🇷 Nantes, Loire Atlantique, France

Service d'Ophtalmologie IV, Hôpital des XV-XX; 🇫🇷 Paris, Ile de France, France

Hôpital Lariboisière, service d'Ophtalmologie; 🇫🇷 Paris, Ile de France, France