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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00970723
First received: September 1, 2009
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Diabetic Retinopathy
Behavioral: high blood pressure treatment
Behavioral: sleep apnea treatment
Behavioral: diabetic macular edema treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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. [ Time Frame: M13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye [ Time Frame: M13 ] [ Designated as safety issue: No ]
  • Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye [ Time Frame: M6-9 ] [ Designated as safety issue: No ]
  • Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye [ Time Frame: M13 ] [ Designated as safety issue: No ]
  • Comparison of blood pressure in each group at one year [ Time Frame: M13 ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: September 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970723

Locations
France
Service d'ophtalmologie, Hôpital de la Vision, La Timone
Marseille, Bouches du Rhone, France, 13005
Service d'Ophtalmologie, Hôpital Avicenne
Bobigny, Ile de france, France, 93009
Service d'Ophtalmologie IV, Hôpital des XV-XX
Paris, Ile de France, France, 75012
Hôpital Lariboisière, service d'Ophtalmologie
Paris, Ile de France, France, 75010
Service d'Ophtalmologie, Hôtel Dieu
Nantes, Loire Atlantique, France, 44093
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pascale MASSIN, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00970723     History of Changes
Other Study ID Numbers: P071227-AOM 08077
Study First Received: September 1, 2009
Last Updated: April 11, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetic retinopathy
Macula edema
Sleep apnea
High blood pressure

Additional relevant MeSH terms:
Apnea
Diabetic Retinopathy
Edema
Hypertension
Macular Edema
Retinal Diseases
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014