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

NCT ID: NCT02599064

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-05-31

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.

Conditions

Age-related Macular Degeneration; Subfoveal Choroidal Neovascularization; Subretinal Scarring; Subretinal Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

RXI-109

Intervention Type: DRUG

RXI-109 dosed intravitreally to subjects with NVAMD

Interventions

RXI-109

RXI-109 dosed intravitreally to subjects with NVAMD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RXi Pharmaceuticals, Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerrit Dispersyn

Role: STUDY_DIRECTOR

RXi Pharmaceuticals

Locations

Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

RXI-109-1501

Identifier Type: -

Identifier Source: org_study_id