The investigation of the effect of dihydralazine (Depressan) on macular edema of type 2 diabetes patients and of inhibition of semicarbazide-sensitive amine oxidase (SSAO). - Dihydralazine trial

• Conditions: Macular edema in patients with type 2 diabetes.; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10012675Term: Diabetic macular retinopathy; MedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edema

• Registration Number: EUCTR2008-002089-74-HU
• Lead Sponsor: Semmelweis University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

30 to 75 years old, both men and women patients with type two diabetes mellitus.
Oral antidiabeticum or insulin is administered as treatment.
Diabetes was diagnosed according to diagnostic criteria of the American Diabetes Association and World Health Organisation.
HbA1c values were measured between 7 to 9 percent.
Blood pressure values in the time of inclusion were measured two times in five minutes and did not exceeded the value of 170/100 Hgmm.
In order to maintain the homogeneity of the group of patients during the time of randomization (within a 14 days period) the average thickness of the central retina (central retinal thickness - CRT) in the patients with diabetic macular edema measured by Optical Coherence Tomorgaphy (OCT) should be within 250-400 microns.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient under 30 years or over 75 years.
HbA1c level above 9%.
Allergy or oversensitivity to dihydralazine, hydralazine or any vehicles
- lupus erythematodes disseminatus (including drug induced cases)
- aorta dilatation
- heart valve stenosis
- hypertensive cardiomyopathy
- decreased performance of the right heart due to high blood pressure in the small blood circle.
Respiratory center depression.
Intracranial pressure elevation.
Progressed (severe) decrease in kidney or liver function
- brain circulation disorders and its complications
- patients with slow metabolism (slow acetylators”)
- coronary diseases
- bradycardia.
Known neoplastic or neurological disease (except diabetic neuropathy), pregnancy, chronic inflammatory disease (e.g. tuberculosis), endocrine disease (except treated hyperthyroidism).
Chronic kidney disease in the previous history (serum albumin higher than 170 mmol/l)
Blood pressure higher than 170/100 Hgmm (with antihypertensive treatment).
Myocardial infarction in the previous 6 months or hospitalization due to any cardiac events, stroke, transient ischemic attack, acute congestive cardiac failure.
Major abdominal, thoracic or intracranial surgical intervention in the previous 3 months or its possibility during the study period.
Any condition preventing the assessment, photography or OCT examination of the fundus (e.g. cornea wounds, cataract, vitreous hemorrhage).
Angle closure glaucoma or its suspicion, which contraindicates regular pupil dilation.
Glaucoma not treated appropriately with eye drops.
Retinal pathologies with major effect on the fundus except diabetic macular edema.
Wet form of atrophic age-related macular degeneration.
Epiretinal membranes or vitreomacular traction detected with OCT.
Myopia greater than 8 dioptries.
Retinal venous or arterial vascular circulatory disorders in previous history.
Any other reason but diabetic retinopathy for macular edema or any pathology that might influence or interfere with OCT measurements of retinal thickness (e.g. taut posterior hyaloid or epiretinal membrane).
Any other ophthalmic condition which, according to the examiner’s opinion, decreases the chance of, or does not allow the absorption of macular edema and would not allow the improvement of visual acuity even after the resolution of the edema (e.g.: foveal atrophy, pigment deviations, dense subfoveal hard exudates, extraretinal causes such as amblyopia).
Patients whose central retinal thickness (CRT) can not be detected with +/- 10% SD accuracy with OCT even with repeated mapping.
Incapability of visual fixation (for any reason).
Visual acuity below 20/200.
Any treatment for diabetic macular edema in the previous 3 months (e.g. focal or grid macular photocoagulation, intravitreal or peribulbar corticosteroids, use of anti-VEGF drugs, or any other treatment).
Panretinal photocoagulation in the previous 3 months.
Need of laser eye surgery within 6 weeks of enrollment or its necessity during the treatment.
Proliferative diabetic retinopathy in the study eye except neovascularization less than one disk diameter in size without intravitreal hemorrhage.
Ocular surgery performed less than three months prior to enrollment or its need during the study (cataract extraction, retinal detachment or any other intraocular surgery).
Aphakic eye.
Participation in any other scientific study 30 days before inclusion or during the study.
Pregnancy or lactation. Women may only take part in the study in case they are on regu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The investigation of the effect of dihydralazine (Depressan) on macular edema in type 2 diabetes patients and the investigation of inhibition of semicarbazide-sensitive amine oxidase (SSAO).;Secondary Objective: ;Primary end point(s): The efficacy of the investigated drug can be judged by the change of SSAO concentration in serum and the level of improvement of clinical symptoms. Efficacy is calculated by statistical methods. A 20 percent decrease of macular edema is considered as clinically significant (expected value:=350+/-90µm), one-sided test, Power=80%, alha.=0.05.