Age-related Macular Degeneration, Subfoveal Choroidal Neovascularization, Subretinal Fibrosis, Subretinal Scarring
Conditions
Keywords
Age-related macular degeneration, RXI-109, NVAMD, Retinal scarring, Subretinal scarring, Retinal fibrosis, Subretinal fibrosis, Eye diseases
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.
Interventions
DRUGRXI-109
RXI-109 dosed intravitreally to subjects with NVAMD
Sponsors
RXi Pharmaceuticals, Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed