Clinical trial NCT00970723: High Blood Pressure and Sleep Apnea in Diabetic Macular Edema
Official title: Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Diabetic retinopathy
Macula edema
Sleep apnea
High blood pressure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: M13
Secondary outcomes:
measure: Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye
timeFrame: M13
measure: Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye
timeFrame: M6-9
measure: Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye
timeFrame: M13
measure: Comparison of blood pressure in each group at one year
timeFrame: M13
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service d'ophtalmologie, Hôpital de la Vision, La Timone
state: Bouches du Rhone
city: Bobigny
country: France
facility: Service d'Ophtalmologie, Hôpital Avicenne
state: Ile de france
city: Paris
country: France
facility: Hôpital Lariboisière, service d'Ophtalmologie
state: Ile de France
city: Paris
country: France
facility: Service d'Ophtalmologie IV, Hôpital des XV-XX
state: Ile de France
city: Nantes
country: France
facility: Service d'Ophtalmologie, Hôtel Dieu
state: Loire Atlantique
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pascale MASSIN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.