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

RXi Pharmaceuticals, Corp.9 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

RXI-109DRUG

RXI-109 dosed intravitreally to subjects with NVAMD

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results

Assess severity and frequency of reported adverse events graded by CTCAE, ophthalmological exams to assess clinically relevant changes in ocular health, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel, and monitoring for any change in best corrected visual acuity (BCVA)

Time frame: Seven (7) months

Pharmacokinetic profile of RXI-109 in blood

Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections

Time frame: Four (4) months

Secondary Outcomes

Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.

Evaluate the clinical activity of RXI-109 to reduce the formation or progression of subretinal fibrosis

Time frame: Seven (7) months

Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart

Evaluate the clinical activity of RXI-109 by assessing changes in visual acuity

Time frame: Seven (7) months

Data from ClinicalTrials.gov

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