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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
2015. "Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02599064.
All > Fibrosis
~1 spots leftby Apr 2025
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