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

Phase 1

• Conditions: Subfoveal Choroidal Neovascularization; Subretinal Scarring; Age-related Macular Degeneration; Subretinal Fibrosis
• Interventions: Drug: RXI-109

• Registration Number: NCT02599064
• Lead Sponsor: RXi Pharmaceuticals, Corp.

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26
• Primary Completion: 2018-04
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RXI-109	RXI-109	Intravitreal injections of RXI-109 in one eye given on Day 1 and at monthly intervals through Month 3 for a total of four doses

Primary Outcome Measures

Name	Time	Method
Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results	Seven (7) months	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)
Pharmacokinetic profile of RXI-109 in blood	Four (4) months	Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections

Secondary Outcome Measures

Name	Time	Method
Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.	Seven (7) months	Evaluate the clinical activity of RXI-109 to reduce the formation or progression of subretinal fibrosis
Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart	Seven (7) months	Evaluate the clinical activity of RXI-109 by assessing changes in visual acuity

Trial Locations

Locations (1)

Wilmer Eye Institute at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States