A clinical trail to assess the effect of a new drug called Eplerenone in patients of Polypoidal Choroidal Vasculopathy, a disease of the seeing layer of eye.
- Conditions
- Health Condition 1: H318- Other specified disorders of choroid
- Registration Number
- CTRI/2019/10/021639
- Lead Sponsor
- Dept of Ophthalmology RPC AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. ICGA diagnosed PCV, that is, presence of early subretinal focal ICGA hyper�uorescence (appearing within the �rst 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) Association with a BVN (ii) Presence of pulsatile polyp (iii) Nodular appearance when viewed stereoscopically (iv) Presence of hypo�uorescent halo (in �rst 6 minutes), (v) Orange subretinal nodules in stereoscopic colour fundus photograph(polyp corresponding to ICGA lesions), or
2. Patient willing to be included in the study
3. BCVA better than 6/60
1. Simultaneous RPE Tear, Retinal detachment, macular hole or uncontrolled glaucoma
2. Previous intraocular surgery except uncomplicated cataract extraction with intraocular lens implantation within 60 days before screening visit
3. Baseline serum potassium concentration of more than 5 Mmol/Lit 4. Pregnancy or planning to conceive
5. BP > 140/90 mmHg
6. Submacular haemorrhage >4 disc diameter
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Best Corrected Visual AcuityTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Complete regression of polyp, Decrement in Choroidal thicknessTimepoint: 6 months