High Blood Pressure and Sleep Apnea in Diabetic Macular Edema (OMHADIA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Behavioral: diabetic macular edema treatment; Behavioral: high blood pressure treatment; Behavioral: sleep apnea treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00970723

P071227-AOM 08077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

intensive treatment

Experimental group

Description:

with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected

Treatment:

Behavioral: sleep apnea treatment

Behavioral: diabetic macular edema treatment

Behavioral: high blood pressure treatment

conventional treatment

Active Comparator group

Description:

in accordance with national guidelines

Treatment:

Behavioral: diabetic macular edema treatment