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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Age-related Macular Degeneration, Subfoveal Choroidal Neovascularization, Subretinal Scarring, Subretinal Fibrosis

Intervention / Treatment
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* Drug: RXI-109


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RXI-109<br>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<br>* RXI-109 dosed intravitreally to subjects with NVAMD<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, RXI-109, NVAMD, Retinal scarring, Subretinal scarring, Retinal fibrosis, Subretinal fibrosis, Eye diseases