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

Sponsor

RXi Pharmaceuticals, Corp. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02599064

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration Subfoveal Choroidal Neovascularization Subretinal Scarring Subretinal Fibrosis	Drug: RXI-109	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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