Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01921192
  4. Details
NCT01921192 Clinical Trial

Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01921192
Other study ID # 1/2012
Secondary ID
Status Recruiting
Phase Phase 4
First received August 8, 2013
Last updated August 8, 2013
Start date September 2012

Study information
Verified date August 2013
Source University of Catania
Contact Mariano Malaguarnera, A.P.
Phone +39(0)957262008
Email malaguar@unict.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

- diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

- Patients with chronic liver disease Patients with kidney disease.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Folic Acid, vit B6 and B12

• Placebo

Locations
Country Name City State
Italy University of Catania, Cannizzaro Hospital Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other vitamin B6 12 months Yes
Other vitamin B12 12 months Yes
Primary homocysteine 12 months Yes
Secondary folic acid 12 months Yes
See also
  Status Clinical Trial Phase
Recruiting NCT01044875 - Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy N/A
Active, not recruiting NCT00993525 - Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study) Phase 1/Phase 2
Completed NCT01307072 - Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy N/A
Completed NCT01758757 - Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy N/A
Withdrawn NCT00600236 - HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population Phase 3
Completed NCT05408416 - Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR N/A
Completed NCT05414149 - Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy N/A
Not yet recruiting NCT04464694 - Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema Phase 4
Not yet recruiting NCT03633266 - Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy N/A
Completed NCT03490318 - Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT00776763 - Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab Phase 2
Terminated NCT00563043 - Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment Phase 4
Terminated NCT00563628 - Changes in Macular Thickness After Patterns Scan Laser Phase 4
Completed NCT00682240 - Morphological and Functional Retinal Changes Following Retinal Photocoagulation Phase 4
Completed NCT00446381 - Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema) N/A
Completed NCT02879422 - Genetic Markers and Proliferative Diabetic Retinopathy N/A
Enrolling by invitation NCT02911311 - Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy N/A
Recruiting NCT05514925 - Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy Phase 4
Completed NCT02858076 - Anti-VEGF vs. Prompt Vitrectomy for VH From PDR Phase 2/Phase 3