High Blood Pressure and Sleep Apnea in Diabetic Macular Edema

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Behavioral: high blood pressure treatment
* Behavioral: sleep apnea treatment
* Behavioral: diabetic macular edema treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive treatment<br>with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected | Behavioral: high blood pressure treatment<br>* over one 14 month period: strongly recommended hygiene-dietetic measurements, complete assessment with ambulatory measurement of the blood pressure in D0, 3 and 12 months, a therapeutic strategy according to the results, and control every 3 months<br>Behavioral: sleep apnea treatment<br>* over one 14 month period: complete assessment with night polysomnography in D0, 3 and 12 months, a therapeutic strategy according to the results, and control every 3 months<br>Behavioral: diabetic macular edema treatment<br>* over one 14 month period: control every 3 months, treatments by laser (focal or grid) are authorized until 9 months, treatments by injections are authorized until 6 months<br>|
| Active Comparator: conventional treatment<br>in accordance with national guidelines | Behavioral: diabetic macular edema treatment<br>* over one 14 month period: control every 3 months, treatments by laser (focal or grid) are authorized until 9 months, treatments by injections are authorized until 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic retinopathy, Macula edema, Sleep apnea, High blood pressure