Clinical Trials Logo
  1. Home
  2. Diabetic Retinopathy
  3. NCT01382498
  4. Details
NCT01382498 Clinical Trial

Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01382498
Other study ID # 88-8
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received May 21, 2010
Last updated June 24, 2011
Start date November 2009

Study information
Verified date April 2011
Source Tabriz University
Contact n/a
Is FDA regulated No
Health authority Iran:Tabriz Medical University Biotechnology research center
Study type Interventional

Clinical Trial Summary

Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- BS 120-200 mg/dl

- Age 40-70

- Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)

- type II diabetes

- no history of doxium consumption

Exclusion Criteria:

- Allergy to doxium

- incidence of active hepatic disease or rising of hepatic enzymes during the intervention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Calcium dobesilate (Doxium)
500 mg, Tablet, Daily, 3 months
• Placebo drug
Similar to the that of the Experimental arm, Daily, Three months

Locations
Country Name City State
Iran, Islamic Republic of Tabriz University of Medical Sciences Tabriz Eastern Azerbayjan

Sponsors (1)
Lead Sponsor Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary high sensitivity CRP and Endothelin-1 serum levels 3 month No
See also
  Status Clinical Trial Phase
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A