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

April 11, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches du Rhone
      • Marseille, Bouches du Rhone, France, 13005
        • Service d'ophtalmologie, Hôpital de la Vision, La Timone
    • Ile de France
      • Paris, Ile de France, France, 75010
        • Hôpital Lariboisière, service d'Ophtalmologie
      • Paris, Ile de France, France, 75012
        • Service d'Ophtalmologie IV, Hôpital des XV-XX
    • Ile de france
      • Bobigny, Ile de france, France, 93009
        • Service d'Ophtalmologie, Hôpital Avicenne
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Service d'Ophtalmologie, Hôtel Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intensive treatment
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
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
Behavioral: sleep apnea treatment
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
Behavioral: diabetic macular edema treatment
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
Active Comparator: conventional treatment
in accordance with national guidelines
Behavioral: diabetic macular edema treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: M13
M13

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Pascale MASSIN, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071227-AOM 08077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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