Skip to content

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.

Efficacy of Oral Eplerenone in Polypoidal Choroidal Vasculopathy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021639
Enrollment
60
Registered
2019-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H318- Other specified disorders of choroid

Interventions

Intervention1: Oral Eplerenone, Intravitreal Aflibercept: Oral Eplerenone 25mg PO OD for 7 days followed by 50mg PO OD, Intravitreal Aflibercept 2mg 0.05ml monthly injection for 3 months Control Inter

Sponsors

Dept of Ophthalmology RPC AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Improvement in Best Corrected Visual AcuityTimepoint: 6 months

Secondary

MeasureTime frame
Complete regression of polyp, Decrement in Choroidal thicknessTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Vipul Singh

All India Institute of Medical Sciences (AIIMS), New Delhi

atul56kumar@yahoo.com01126593185

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026