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

A

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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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