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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high blood pressure treatment
sleep apnea treatment
diabetic macular edema treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic retinopathy, Macula edema, Sleep apnea, High blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service d'ophtalmologie, Hôpital de la Vision, La Timone
  • Service d'Ophtalmologie, Hôpital Avicenne
  • Hôpital Lariboisière, service d'Ophtalmologie
  • Service d'Ophtalmologie IV, Hôpital des XV-XX
  • Service d'Ophtalmologie, Hôtel Dieu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intensive treatment

conventional treatment

Arm Description

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

in accordance with national guidelines

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2009
Last Updated
April 11, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00970723
Brief Title
High Blood Pressure and Sleep Apnea in Diabetic Macular Edema
Acronym
OMHADIA
Official Title
Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetic retinopathy, Macula edema, Sleep apnea, High blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive treatment
Arm Type
Experimental
Arm Description
with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
in accordance with national guidelines
Intervention Type
Behavioral
Intervention Name(s)
high blood pressure treatment
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
sleep apnea treatment
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
diabetic macular edema treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye
Time Frame
M13
Title
Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye
Time Frame
M6-9
Title
Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye
Time Frame
M13
Title
Comparison of blood pressure in each group at one year
Time Frame
M13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale MASSIN, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'ophtalmologie, Hôpital de la Vision, La Timone
City
Marseille
State/Province
Bouches du Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
Service d'Ophtalmologie, Hôpital Avicenne
City
Bobigny
State/Province
Ile de france
ZIP/Postal Code
93009
Country
France
Facility Name
Hôpital Lariboisière, service d'Ophtalmologie
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75010
Country
France
Facility Name
Service d'Ophtalmologie IV, Hôpital des XV-XX
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75012
Country
France
Facility Name
Service d'Ophtalmologie, Hôtel Dieu
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16303968
Citation
Paques M, Massin P, Sahel JA, Gaudric A, Bergmann JF, Azancot S, Levy BI, Vicaut E. Circadian fluctuations of macular edema in patients with morning vision blurring: correlation with arterial pressure and effect of light deprivation. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4707-11. doi: 10.1167/iovs.05-0638.
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High Blood Pressure and Sleep Apnea in Diabetic Macular Edema

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