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siRNA

RXI-109 for Age-Related Macular Degeneration

Phase 1 & 2
Waitlist Available
Research Sponsored by RXi Pharmaceuticals, Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up seven (7) months
Awards & highlights

Study 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).

Eligible Conditions
  • Age-Related Macular Degeneration
  • Subretinal Scarring
  • Subretinal Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~seven (7) months
This trial's timeline: 3 weeks for screening, Varies for treatment, and seven (7) months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results
Pharmacokinetic profile of RXI-109 in blood
Secondary outcome measures
Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart
Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.
Other outcome measures
Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline

Trial Design

1Treatment groups
Experimental Treatment
Group I: RXI-109Experimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RXI-109
2012
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

RXi Pharmaceuticals, Corp.Lead Sponsor
6 Previous Clinical Trials
194 Total Patients Enrolled
Gerrit DispersynStudy DirectorRXi Pharmaceuticals
~1 spots leftby Jun 2025
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