High-dose Antioxidants for Central Serous Chorioretinopathy

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT00963131
First received: August 20, 2009
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually involves the macular area. It is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. The common risk factors are psychologic stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment is usually observation especially in the first three-months. The laser or photodynamic therapy should be considered when the condition does not improve after that time. Nevertheless, the pathogenesis of CSC is still not well understood but the study from indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins or even free oxidative radicals. From this hypothesis, the oxidative process might be involved in the pathogenesis of the disease especially in the early stage. This study is to determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether they can improve the outcomes of the disease.


Condition Intervention Phase
Central Serous Chorioretinopathy
Drug: antioxidants tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: High-dose Antioxidants for Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • visual acuity and central macular thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fluorescein leakage at the third month [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2004
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antioxidant tablets
the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease
Drug: antioxidants tablets
vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.
Other Name: Icaps
Placebo Comparator: placebo tablets
the control arm received placebo tablets for 3 months or until the resolution of the disease
Drug: antioxidants tablets
vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.
Other Name: Icaps

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients with acute central serous chorioretinopathy within 6 weeks of onset
  2. age between 30-50 years
  3. new or recurrent attack (the symptom-free period should longer than 6 months)
  4. fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (OCT) showed definite subretinal fluid
  5. patients' ability for proper follow up.

Exclusion Criteria:

  1. chronic central serous chorioretinopathy(longer than 6 weeks)
  2. complicated central serous chorioretinopathy such as secondary choroidal neovascularization (CNV) that detected from FA
  3. pregnancy, steroid user and patients that contraindicated for high dose antioxidants therapy such as heavy smokers, lung cancer, thyrotoxicosis, renal stone and anemia (hematocrit less than 30%).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963131

Locations
Thailand
Department of Ophthalmology, Faculty of medicine, Prince of Songkla university
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Alcon Laboratories
Investigators
Principal Investigator: Mansing - Ratnasukon, MD Department of Ophthalmology, Faculty of medicine, Prince of Songkla university, Hat yai, Songkhla province, Thailand 90110
  More Information

No publications provided

Responsible Party: Associated professor Mansing Ratanasukon, MD, Department of Ophthalmology, Faculty of medicine, Prince of Songkla university
ClinicalTrials.gov Identifier: NCT00963131     History of Changes
Other Study ID Numbers: EC 47/362-023, PSU 2547
Study First Received: August 20, 2009
Last Updated: December 29, 2009
Health Authority: Ethics committee board of Faculty of medicine, Prince of Songkla university, Thailand:

Keywords provided by Prince of Songkla University:
Central serous chorioretinopathy,antioxidants

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014