High Blood Pressure and Sleep Apnea in Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

— OMHADIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970723
• Other study ID #: P071227-AOM 08077
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: April 11, 2014
• Start date: September 2009
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hypertension
• Macular Edema
• Retinal Diseases

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
France	Service d'Ophtalmologie, Hôpital Avicenne	Bobigny	Ile de france
France	Service d'ophtalmologie, Hôpital de la Vision, La Timone	Marseille	Bouches du Rhone
France	Service d'Ophtalmologie, Hôtel Dieu	Nantes	Loire Atlantique
France	Hôpital Lariboisière, service d'Ophtalmologie	Paris	Ile de France
France	Service d'Ophtalmologie IV, Hôpital des XV-XX	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Paques M, Massin P, Sahel JA, Gaudric A, Bergmann JF, Azancot S, Lévy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye		M13	No
Secondary	Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye		M6-9	No
Secondary	Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye		M13	No
Secondary	Comparison of blood pressure in each group at one year		M13	No