Back to resultsEvaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
Primary Purpose
Age-related Macular Degeneration, Subfoveal Choroidal Neovascularization, Subretinal Scarring
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RXI-109
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Age-related macular degeneration, RXI-109, NVAMD, Retinal scarring, Subretinal scarring, Retinal fibrosis, Subretinal fibrosis, Eye diseases
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
Sites / Locations
- Wilmer Eye Institute at Johns Hopkins
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RXI-109
Arm Description
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
Outcomes
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
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)
Pharmacokinetic profile of RXI-109 in blood
Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02599064
First Posted
November 3, 2015
Last Updated
February 22, 2018
Sponsor
RXi Pharmaceuticals, Corp.
1. Study Identification
Unique Protocol Identification Number
NCT02599064
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RXi Pharmaceuticals, Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RXI-109
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
RXI-109
Intervention Description
RXI-109 dosed intravitreally to subjects with NVAMD
Primary Outcome Measure Information:
Title
Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results
Description
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)
Time Frame
Seven (7) months
Title
Pharmacokinetic profile of RXI-109 in blood
Description
Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections
Time Frame
Four (4) months
Secondary Outcome Measure Information:
Title
Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.
Description
Evaluate the clinical activity of RXI-109 to reduce the formation or progression of subretinal fibrosis
Time Frame
Seven (7) months
Title
Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart
Description
Evaluate the clinical activity of RXI-109 by assessing changes in visual acuity
Time Frame
Seven (7) months
Other Pre-specified Outcome Measures:
Title
Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline
Description
Evaluate the clinical activity of RXI-109 by assessing changes in CTGF protein levels in aqueous fluid
Time Frame
Seven (7) months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerrit Dispersyn
Organizational Affiliation
RXi Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Wilmer Eye Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
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