An interventional study of high blood pressure treatment and sleep apnea treatment in Diabetic Retinopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.
This study's enrollment of 86 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,504 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
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
in accordance with national guidelines
Behavioral: diabetic macular edema 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
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
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
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
Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye
Time frame: M13
Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye
Time frame: M6-9
Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye
Time frame: M13
Comparison of blood pressure in each group at one year
Time frame: M13
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris