Diabetic RetinopathyOMHADIANCT00970723
High Blood Pressure and Sleep Apnea in Diabetic Macular Edema
A study testing high blood pressure treatment, sleep apnea treatment and diabetic macular edema treatment in people with Diabetic Retinopathy, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- high blood pressure treatment, sleep apnea treatment and diabetic macular edema treatment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service d'Ophtalmologie, Hôpital Avicenne
Bobigny, Île-de-France Region, 93009
Service d'ophtalmologie, Hôpital de la Vision, La Timone
Marseille, Bouches du Rhone, 13005
Service d'Ophtalmologie, Hôtel Dieu
Nantes, Loire Atlantique, 44093
Hôpital Lariboisière, service d'Ophtalmologie
Paris, Île-de-France Region, 75010
Service d'Ophtalmologie IV, Hôpital des XV-XX
Paris, Île-de-France Region, 75012
About this study
Official title: Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema
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.
Read the 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.
- Conditions
- Diabetic Retinopathy
- Being tested
- high blood pressure treatment, sleep apnea treatment, diabetic macular edema treatment
- Keywords
- Diabetic retinopathy, Macula edema, Sleep apnea, High blood pressure
- Medical subject headings
- Diabetic Retinopathy, Sleep Apnea Syndromes, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high blood pressure treatmentBehavioural
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 treatmentBehavioural
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 treatmentBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| intensive treatment | Experimental | with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected Receives: Behavioral: high blood pressure treatment; Behavioral: sleep apnea treatment; Behavioral: diabetic macular edema treatment |
| conventional treatment | Active comparator | in accordance with national guidelines Receives: Behavioral: diabetic macular edema treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: M13
Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye
Measured: M6-9
Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye
Measured: M13
Comparison of blood pressure in each group at one year
Measured: M13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale MASSIN, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970723
- Sponsor's protocol ID
- P071227-AOM 08077
- Acronym
- OMHADIA
- Status last verified
- Apr 2014
- First submitted
- 1 Sep 2009
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16303968
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00970723
- Acronym / sponsor ID
- OMHADIA / P071227-AOM 08077
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic retinopathy, Macula edema, Sleep apnea, High blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive treatment | Experimental | Behavioral: high blood pressure treatment, Behavioral: sleep apnea treatment, Behavioral: diabetic macular edema treatmentwith a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected |
| conventional treatment | Active comparator | Behavioral: diabetic macular edema treatmentin accordance with national guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high blood pressure treatmentover 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 | Behavioural | intensive treatment |
| sleep apnea treatmentover 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 | Behavioural | intensive treatment |
| diabetic macular edema treatmentover 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 | Behavioural | conventional treatment, intensive treatment |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Background: PubMed 16303968Paques 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale MASSIN, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high blood pressure treatment, sleep apnea treatment and diabetic macular edema treatment in people with Diabetic Retinopathy, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: M13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.