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

NCT02599064 | Unknown Phase 1 DMC

• 1 other identifier: RXI-109-1501
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.

  Seven (7) months

• Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart

  Seven (7) months

Other Outcomes (1)

• Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline

  Seven (7) months

Study Arms (1)

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

Drug: RXI-109

Interventions

RXI-109 DRUG

RXI-109 dosed intravitreally to subjects with NVAMD

RXI-109

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RXi Pharmaceuticals, Corp.: lead

Study Sites (1)

Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, 21014, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Eye Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases

Study Officials

• Gerrit Dispersyn

  RXi Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

US (1)