Age-related Macular DegenerationPhase 1/2NCT02599064
Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
A Phase 1/2 study testing RXI-109 in people with Age-related Macular Degeneration and Subfoveal Choroidal Neovascularization, run by RXi Pharmaceuticals, Corp. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Subfoveal Choroidal Neovascularization, Subretinal Scarring
- What is being tested?
- RXI-109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to May 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, 21014
About this study
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
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).
Read the 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.
- Conditions
- Age-related Macular Degeneration, Subfoveal Choroidal Neovascularization, Subretinal Scarring, Subretinal Fibrosis
- Being tested
- RXI-109
- Keywords
- Age-related macular degeneration, RXI-109, NVAMD, Retinal scarring, Subretinal scarring, Retinal fibrosis, Subretinal fibrosis, Eye diseases
- Medical subject headings
- Macular Degeneration, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXI-109Drug
RXI-109 dosed intravitreally to subjects with NVAMD
| Study group | Role | What they receive |
|---|---|---|
| RXI-109 | Experimental | 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 Receives: Drug: RXI-109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Seven (7) months
Pharmacokinetic profile of RXI-109 in blood
Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections
Measured: Four (4) months
Secondary outcomes (2)
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
Measured: Seven (7) months
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
Measured: Seven (7) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RXi Pharmaceuticals, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerrit Dispersyn, Study director, RXi Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599064
- Sponsor's protocol ID
- RXI-109-1501
- Status last verified
- Feb 2018
- First submitted
- 3 Nov 2015
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02599064
- Acronym / sponsor ID
- RXI-109-1501
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- RXi Pharmaceuticals, Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RXI-109 | Experimental | Drug: RXI-109Intravitreal injections of RXI-109 in one eye given on Day 1 and at monthly intervals through Month 3 for a total of four doses |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXI-109RXI-109 dosed intravitreally to subjects with NVAMD | Drug | RXI-109 |
Primary outcome
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)
Pharmacokinetic profile of RXI-109 in blood
Time frame: Four (4) months
Determine systemic exposure (AUC) of RXI-109 after intra-ocular injections
2 secondary outcomes
Relative change (%) of subretinal fibrosis lesion size compared to baseline using standard ophthalmologic imaging.
Time frame: Seven (7) months
Changes from baseline in BCVA using the Early Treatment Diabetic Retinopathy (ETDRS) chart
Time frame: Seven (7) months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerrit Dispersyn study director
RXi Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RXI-109 in people with Age-related Macular Degeneration and Subfoveal Choroidal Neovascularization, run by RXi Pharmaceuticals, Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.