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

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ClinicalTrials.gov Identifier: NCT02599064
Recruitment Status : Active, not recruiting
First Posted : November 6, 2015
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.

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).

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Subfoveal Choroidal Neovascularization Subretinal Scarring Subretinal Fibrosis Drug: RXI-109 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RXI-109
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
RXI-109 dosed intravitreally to subjects with NVAMD




Primary Outcome Measures :
  1. Incidence, severity and relationship of AEs, including clinically significant changes in physical examination findings, ocular examinations and assessments, and clinical laboratory results [ Time Frame: Seven (7) months ]
    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)

  2. Pharmacokinetic profile of RXI-109 in blood [ Time Frame: Four (4) months ]
    Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections


Secondary Outcome Measures :
  1. Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging. [ Time Frame: Seven (7) months ]
    Evaluate the clinical activity of RXI-109 to reduce the formation or progression of subretinal fibrosis

  2. Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart [ Time Frame: Seven (7) months ]
    Evaluate the clinical activity of RXI-109 by assessing changes in visual acuity


Other Outcome Measures:
  1. Relative change (%) of CTGF protein levels in aqueous fluid compared to baseline [ Time Frame: Seven (7) months ]
    Evaluate the clinical activity of RXI-109 by assessing changes in CTGF protein levels in aqueous fluid



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599064


Locations
United States, Maryland
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21014
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
Investigators
Study Director: Gerrit Dispersyn RXi Pharmaceuticals

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT02599064     History of Changes
Other Study ID Numbers: RXI-109-1501
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Keywords provided by RXi Pharmaceuticals, Corp.:
Age-related macular degeneration
RXI-109
NVAMD
Retinal scarring
Subretinal scarring
Retinal fibrosis
Subretinal fibrosis
Eye diseases

Additional relevant MeSH terms:
Fibrosis
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Cicatrix
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Choroid Diseases
Uveal Diseases