Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 8/3/2016 |
| Start Date: | November 2015 |
| End Date: | September 2017 |
| Contact: | Clinical Trials Manager |
| Email: | clinicaloperations@rxipharma.com |
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
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).
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.
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.
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
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