Geographic Atrophy (GA)Phase 1VIENNANCT07230834
Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants
A Phase 1 study testing Pozelimab in people with Geographic Atrophy (GA), run by Regeneron Pharmaceuticals at 9 sites in 4 countries.
Trial summary
This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy (GA)
- What is being tested?
- Pozelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 19 Jan 2026to 3 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator
- Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol
- Best-Corrected Visual Acuity (BCVA) of 60 letters or worse using the Early Treatment Diabetic Retinopathy Score (ETDRS) charts (Snellen equivalent of ~ ≤20/63) in the study eye at screening and baseline visit
Who cannot join
- GA (macular atrophy) in either eye due to causes other than dry AMD
- History or current evidence of macular neovascularization and/or retinal exudation in either eye
- Concurrent eye disease (elevated Intraocular Pressure (IOP) >25mm Hg, diabetic retinopathy, ocular infections/inflammation)
- Prior or current intravitreal (IVT) treatment of any kind for any indication in either the study or fellow eye, except complement inhibitor therapy for GA, as long as last dose was ≥3 months prior to screening
- Any prior systemic treatment for dry AMD, except oral supplements or vitamins
- History or current use of systemic complement inhibitor therapy
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
United States5 sites, 5 recruiting
- Recruiting
Austin Retina Associates
Austin, Texas, 78705
- Recruiting
Retina Foundation of the Southwest
Dallas, Texas, 75231
- Recruiting
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, 02189
- Recruiting
Colorado Retina Associates
Lakewood, Colorado, 80228
- Recruiting
Retina Consultants Texas
The Woodlands, Texas, 77384
Romania2 sites, 2 recruiting
- Recruiting
ARENSIA Clinics SRL
Bucharest, 011658
- Recruiting
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, 400006
Georgia1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine at the Research Institute of Clinical Medicine
Tbilisi, 0112
Puerto Rico1 site, 1 recruiting
- Recruiting
Emanuelli Research and Development Center
Arecibo, 00612
About this study
Official title: A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy
This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA).
The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.
Read more
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood and the fluid in the eye at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Conditions
- Geographic Atrophy (GA)
- Being tested
- Pozelimab
- Keywords
- Age-related Macular Degeneration (AMD), GA secondary to AMD
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PozelimabDrug
Also called REGN3918
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Pozelimab |
| Part B | Experimental | Not described Receives: Drug: Pozelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye
Part A
Measured: Through week 8
Occurrence of ocular TEAEs in the study eye
Part B
Measured: Through week 16
Occurrence of systemic TEAEs
Part A
Measured: Through week 8
Occurrence of systemic TEAEs
Part B
Measured: Through week 16
Secondary outcomes (6)
Concentrations of pozelimab in serum
Part A
Measured: Through week 8
Concentrations of pozelimab in serum
Part B
Measured: Through week 16
Occurrence of Anti-Drug Antibody (ADA) to pozelimab
Part A
Measured: Through week 8
Magnitude of ADA to pozelimab
Part A
Measured: Through week 8
Occurrence of ADA to pozelimab
Part B
Measured: Through week 16
Magnitude of ADA to pozelimab
Part B
Measured: Through week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start19 Jan 2026
- Primary completion3 Jul 2028 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy (GA)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230834
- Sponsor's protocol ID
- R3918-AMD-2501
- Other IDs
- 2025-521758-40-00, 2025
- Acronym
- VIENNA
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy
- ClinicalTrials.gov ID
- NCT07230834
- Acronym / sponsor ID
- VIENNA / R3918-AMD-2501
- Conditions
- Geographic Atrophy (GA)
- Keywords
- Age-related Macular Degeneration (AMD), GA secondary to AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- 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 researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA).
The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood and the fluid in the eye at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Pozelimab |
| Part B | Experimental | Drug: Pozelimab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator
- Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol
- Best-Corrected Visual Acuity (BCVA) of 60 letters or worse using the Early Treatment Diabetic Retinopathy Score (ETDRS) charts (Snellen equivalent of ~ ≤20/63) in the study eye at screening and baseline visit
Key exclusion criteria (7 listed)
- GA (macular atrophy) in either eye due to causes other than dry AMD
- History or current evidence of macular neovascularization and/or retinal exudation in either eye
- Concurrent eye disease (elevated Intraocular Pressure (IOP) >25mm Hg, diabetic retinopathy, ocular infections/inflammation)
- Prior or current intravitreal (IVT) treatment of any kind for any indication in either the study or fellow eye, except complement inhibitor therapy for GA, as long as last dose was ≥3 months prior to screening
- Any prior systemic treatment for dry AMD, except oral supplements or vitamins
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 |
|---|---|---|
| PozelimabAlso: REGN3918Administered per the protocol | Drug | Part A, Part B |
Primary outcome
Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye
Time frame: Through week 8
Part A
Occurrence of ocular TEAEs in the study eye
Time frame: Through week 16
Part B
Occurrence of systemic TEAEs
Time frame: Through week 8
Part A
Occurrence of systemic TEAEs
Time frame: Through week 16
Part B
6 secondary outcomes
Concentrations of pozelimab in serum
Time frame: Through week 8
Concentrations of pozelimab in serum
Time frame: Through week 16
Occurrence of Anti-Drug Antibody (ADA) to pozelimab
Time frame: Through week 8
Magnitude of ADA to pozelimab
Time frame: Through week 8
Occurrence of ADA to pozelimab
Time frame: Through week 16
Magnitude of ADA to pozelimab
Time frame: Through week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Related trials for Geographic Atrophy (GA)
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
RecruitingObservational study
A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)
Geographic Atrophy Secondary to Age-related Macular Degeneration
RecruitingPhase 1/2
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
Geographic Atrophy Secondary to Age-related Macular Degeneration
Active, not recruitingPhase 3
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
Geographic Atrophy
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pozelimab in people with Geographic Atrophy (GA), run by Regeneron Pharmaceuticals at 9 sites in 4 countries.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Romania, Georgia, Puerto Rico. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye (time frame: Through week 8). The study lists 4 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 5 Aug 2026.