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

Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02599064
• Other study ID #: RXI-109-1501
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 3, 2015
• Last updated: February 22, 2018
• Start date: November 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2018
• Source: RXi Pharmaceuticals, Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascularization
• Cicatrix
• Fibrosis
• Macular Degeneration
• Neovascularization, Pathologic
• Subfoveal Choroidal Neovascularization
• Subretinal Fibrosis
• Subretinal Scarring

Intervention

Drug:
• RXI-109
RXI-109 dosed intravitreally to subjects with NVAMD

Locations

Country	Name	City	State
United States	Wilmer Eye Institute at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
RXi Pharmaceuticals, Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline	Evaluate the clinical activity of RXI-109 by assessing changes in CTGF protein levels in aqueous fluid	Seven (7) months
Primary	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
Primary	Pharmacokinetic profile of RXI-109 in blood	Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections	Four (4) months
Secondary	Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.	Evaluate the clinical activity of RXI-109 to reduce the formation or progression of subretinal fibrosis	Seven (7) months
Secondary	Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart	Evaluate the clinical activity of RXI-109 by assessing changes in visual acuity	Seven (7) months