High Blood Pressure and Sleep Apnea in Diabetic Macular Edema

NCT00970723 | Completed

• 1 other identifier: P071227-AOM 08077
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy; Macula edema; Sleep apnea; High blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

intensive treatment

EXPERIMENTAL

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; Behavioral: sleep apnea treatment; Behavioral: diabetic macular edema treatment

conventional treatment

ACTIVE COMPARATOR

in accordance with national guidelines

Behavioral: diabetic macular edema treatment

Interventions

high blood pressure treatment BEHAVIORAL

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

intensive treatment

sleep apnea treatment BEHAVIORAL

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

intensive treatment

diabetic macular edema treatment BEHAVIORAL

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

conventional treatment; intensive treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

Service d'ophtalmologie, Hôpital de la Vision, La Timone

Marseille, Bouches du Rhone, 13005, France

Location

Service d'Ophtalmologie, Hôtel Dieu

Nantes, Loire Atlantique, 44093, France

Location

Service d'Ophtalmologie, Hôpital Avicenne

Bobigny, Île-de-France Region, 93009, France

Location

Hôpital Lariboisière, service d'Ophtalmologie

Paris, Île-de-France Region, 75010, France

Location

Service d'Ophtalmologie IV, Hôpital des XV-XX

Paris, Île-de-France Region, 75012, France

Location

Related Publications (1)

• 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.

  PMID: 16303968 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Sleep Apnea Syndromes; Hypertension

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Pascale MASSIN, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

FR (5)