Neovascular Age-related Macular DegenerationPhase 2NCT05275205
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
A Phase 2 study testing UBX1325 injection 50 μL and EYLEA® (aflibercept) Injection 2 mg (0.05mL) in people with Neovascular Age-related Macular Degeneration, run by Unity Biotechnology, Inc. at 14 sites in United States.
Trial summary
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- UBX1325 injection 50 μL and EYLEA® (aflibercept) Injection 2 mg (0.05mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Mar 2022to 25 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients aged ≥50 years.
- Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
- BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
- Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.
Who cannot join
- Concurrent disease in the study eye or structural damage, other than wet AMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye.
- Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening
- Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
- History of vitreous hemorrhage in the study eye within 2 months prior to Screening
- Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
- Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Retina Research Institution of Texas
Abilene, Texas, 79606
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Midwest Eye
Carmel, Indiana, 46290
Rand Eye Institute
Deerfield Beach, Florida, 33064
Salehi Retina Institute
Huntington Beach, California, 92647
University Retina and Macula Associates
Lemont, Illinois, 60439
Advanced Vision Research Institute
Longmont, Colorado, 80503
Valley Retina Institute
McAllen, Texas, 78503
Illinois Eye Center
Peoria, Illinois, 61615
EyeHealth Northwest
Portland, Oregon, 97225
Sierra Eye Associates
Reno, Nevada, 89502
Mayo Clinic-Rochester
Rochester, Minnesota, 55905
Austin Retina Associates
Round Rock, Texas, 78681
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
About this study
Official title: A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (Wet AMD)
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
Read the detailed description
This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
- Being tested
- UBX1325 injection 50 μL, EYLEA® (aflibercept) Injection 2 mg (0.05mL)
- Keywords
- Wet AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBX1325 injection 50 μLDrug
Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
EYLEA® (aflibercept) Injection 2 mg (0.05mL)Drug
Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
| Study group | Role | What they receive |
|---|---|---|
| UBX1325 | Experimental | Not described Receives: Drug: UBX1325 injection 50 μL |
| Aflibercept (EYLEA ®) | Active comparator | Not described Receives: Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24
Measured: Through 24 weeks
Secondary outcomes (3)
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart starting at 4 meters.
Measured: Through 48 weeks
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Central Subfield Thickness (CST) measured in microns using spectral domain optical coherence tomography (SD-OCT).
Measured: Through 48 weeks
Adverse Events (Safety)
Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs).
Measured: Through 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start2 Mar 2022
- Primary completion15 Feb 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Klier, MD, MPH, Study director, Unity Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275205
- Sponsor's protocol ID
- UBX1325-03
- Status last verified
- Oct 2023
- First submitted
- 17 Feb 2022
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (Wet AMD)
- ClinicalTrials.gov ID
- NCT05275205
- Acronym / sponsor ID
- UBX1325-03
- Keywords
- Wet AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Unity Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Posted 7 Aug 2024
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 intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
Detailed description
This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBX1325 | Experimental | Drug: UBX1325 injection 50 μL |
| Aflibercept (EYLEA ®) | Active comparator | Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥50 years.
- Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
- BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
- Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.
Key exclusion criteria (6 listed)
- Concurrent disease in the study eye or structural damage, other than wet AMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye.
- Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening
- Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
- History of vitreous hemorrhage in the study eye within 2 months prior to Screening
- Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
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 |
|---|---|---|
| UBX1325 injection 50 μLPatients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28 | Drug | UBX1325 |
| EYLEA® (aflibercept) Injection 2 mg (0.05mL)Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28. | Drug | Aflibercept (EYLEA ®) |
Primary outcome
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
Time frame: Through 24 weeks
Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24
3 secondary outcomes
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
Time frame: Through 48 weeks
Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center
Time frame: Through 48 weeks
Adverse Events (Safety)
Time frame: Through 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sharon Klier, MD, MPH study director
Unity Biotechnology, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UBX1325 injection 50 μL and EYLEA® (aflibercept) Injection 2 mg (0.05mL) in people with Neovascular Age-related Macular Degeneration, run by Unity Biotechnology, Inc. at 14 sites 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 6 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: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control (time frame: Through 24 weeks). 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 7 Aug 2024.