A randomized double blinded sham-controlled study to determine the efficacy and safety of dexamethasone implants in chronic central serous chorioretinopathy

Not Applicable

• Conditions: Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere

• Registration Number: CTRI/2023/06/053775
• Lead Sponsor: Hyderabad Eye Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adults of both genders aged 30 years or more

2.Diagnosis of cCSC confirmed at screening visit by complete ocular examination and multimodal imaging in the study eye

3.Best corrected vision score of 73 to 19 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20/40 to 20/400)

4.Decrease in vision primarily secondary to cCSC

5.Willing to sign informed consent form before initiation of any study related procedure.

Exclusion Criteria

1.Patients not able to comply with the study or follow up procedures

2.Laser/ PDT treatment for CSC within 3 months of enrolment

3.Use of corticosteroids in all forms within 3 months of enrolment

4.Pharmacological treatment (eplerenone) for CSC within a month of enrolment

5.Eyes with choroidal neovascularization demonstrable on multimodal imaging (OCTA/FA/ICGA)

6.Non-study eye vision of <20/200,

7.Aphakia in study eye

8.History of glaucoma in either eye (IOP >24 mmHg)

9.Cataract grade dense enough to affect retinal imaging

10.History of hypersensitivity to fluorescein dye

11.Presence of sub-retinal fluid (SRF) or intra-retinal fluid (IRF) secondary to causes other than CSC

12.Presence of active infectious disease or intra-ocular inflammation, active or suspected periocular infection in either eye at the time of enrolment

13.History of intra-ocular surgery within 3 months in the study eye prior to the randomization

14.Pregnancy induced CSC.

Study & Design

• Study Type: Interventional
• Study Design: Not specified