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

A Phase 1/2 Multicenter, Multidose, Dose Escalation Study 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

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).

Study Overview

• Status: Unknown
• Conditions: Age-related Macular Degeneration; Subfoveal Choroidal Neovascularization; Subretinal Scarring; Subretinal Fibrosis
• Intervention / Treatment: Drug: RXI-109

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 Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21014
      • Wilmer Eye Institute at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: RXI-109; RXI-109 dosed intravitreally to subjects with NVAMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Seven (7) months
Pharmacokinetic profile of RXI-109 in blood	Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections	Four (4) months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Seven (7) months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline	Evaluate the clinical activity of RXI-109 by assessing changes in CTGF protein levels in aqueous fluid	Seven (7) months

Collaborators and Investigators

• Sponsor: RXi Pharmaceuticals, Corp.
• Investigators: Study Director: Gerrit Dispersyn, RXi Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Age-related macular degeneration; Eye diseases; NVAMD; RXI-109; Retinal scarring; Subretinal scarring; Retinal fibrosis; Subretinal fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Fibrosis; Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Cicatrix
• Other Study ID Numbers: RXI-109-1501