Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RXI-109 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RXI-109 | Drug | RXI-109 dosed intravitreally to subjects with NVAMD |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gerrit Dispersyn | RXi Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute at Johns Hopkins | Baltimore | Maryland | 21014 | United States |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the clinical activity of RXI-109 by assessing changes in visual acuity |
| Seven (7) months |