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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 : Recruiting
First Posted : November 6, 2015
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):

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).

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 Design

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 : July 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Incidence, severity and relationship of AEs [ 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. Pharmacokinetics (PK) of RXI-109 by intravitreal injection following single and multiple doses [ Time Frame: Four (4) months ]
    Determine peak whole blood concentration (Cmax)

  3. Pharmacokinetics (PK) of RXI-109 by intravitreal injection following single and multiple doses [ Time Frame: Four (4) months ]
    Determine area under the whole blood concentration versus time curve (AUC)

  4. Pharmacokinetics (PK) of RXI-109 by intravitreal injection following single and multiple doses [ Time Frame: Four (4) months ]
    Determine drug half-life in whole blood (T1/2)


Secondary Outcome Measures :
  1. Evaluate the clinical activity of RXI-109 [ Time Frame: Seven (7) months ]
    Evaluate the clinical activity of RXI-109 to reduce the formation or progression of subretinal fibrosis by assessing changes in lesion(s) by standard ophthalmological testing including optical coherence tomography (OCT) and fluorescein angiography (FA), and changes in best corrected visual acuity (BCVA)


Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Clinical Trials Manager clinicaloperations@rxipharma.com

Locations
United States, Maryland
Wilmer Eye Institute at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21014
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
Investigators
Study Director: Pamela A Pavco, PhD RXi Pharmaceuticals
More Information

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: August 5, 2016
Last Verified: August 2016

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