High-dose Antioxidants for Central Serous Chorioretinopathy

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.

Study Overview

• Status: Completed
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Drug: antioxidants tablets

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Icaps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
visual acuity and central macular thickness	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
fluorescein leakage at the third month	6 months

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Mansing - Ratnasukon, MD, Department of Ophthalmology, Faculty of medicine, Prince of Songkla university, Hat yai, Songkhla province, Thailand 90110

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Estimate): December 30, 2009
• Last Update Submitted That Met QC Criteria: December 29, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Central serous chorioretinopathy,antioxidants
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: EC 47/362-023; PSU 2547 (Other Identifier: Prince of Songkla University)