Clinical trial NCT02599064: Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Age-related Macular Degeneration
Subfoveal Choroidal Neovascularization
Subretinal Scarring
Subretinal Fibrosis
Keywords: Age-related macular degeneration
RXI-109
NVAMD
Retinal scarring
Subretinal scarring
Retinal fibrosis
Subretinal fibrosis
Eye diseases
Lead sponsor: RXi Pharmaceuticals, Corp.
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results
timeFrame: Seven (7) months
measure: Pharmacokinetic profile of RXI-109 in blood
timeFrame: Four (4) months
Secondary outcomes:
measure: Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.
timeFrame: Seven (7) months
measure: Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart
timeFrame: Seven (7) months
Other outcomes:
measure: Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline
timeFrame: Seven (7) months
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute at Johns Hopkins
state: Maryland
Study officials:
affiliation: RXi Pharmaceuticals
name: Gerrit Dispersyn
role: STUDY_DIRECTOR
References: