High-dose Antioxidants for Central Serous Chorioretinopathy

Prince of Songkla University

Status and phase: Completed; Phase 2

Conditions: Central Serous Chorioretinopathy

Treatments: Drug: antioxidants tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00963131

EC 47/362-023

PSU 2547 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

antioxidant tablets

Experimental group

Description:

the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease

Treatment:

Drug: antioxidants tablets

placebo tablets

Placebo Comparator group

Description:

the control arm received placebo tablets for 3 months or until the resolution of the disease

Treatment:

Drug: antioxidants tablets