Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD

RXi Pharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Age-related Macular Degeneration

Subretinal Fibrosis

Subfoveal Choroidal Neovascularization

Subretinal Scarring

Treatments

Drug: RXI-109

Study type

Interventional

Funder types

Industry

Identifiers

NCT02599064

RXI-109-1501

Details and patient eligibility

About

This study is designed to evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration (NVAMD).

Full description

Evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple doses of RXI-109 when administered by intravitreal injection. Evaluate the clinical activity of single and multiple doses of RXI-109 when administered by intravitreal injection. Study participation is intended to be seven months from time of initial treatment with RXI-109.

Enrollment

9 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/100 potentially due to subretinal fibrosis involving the fovea
BCVA ≥20/800 in the contralateral eye and better than the study eye
≥50 years of age
Subfoveal choroidal neovascularization (CNV) of any type

Exclusion criteria

Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis
Evidence of inflammation (Grade 1 or higher) in the anterior or posterior chamber