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Neovascular Age-Related Macular Degeneration (nAMD)Phase 2NCT05210803

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

A Phase 2 study testing Ranibizumab in people with Neovascular Age-Related Macular Degeneration (nAMD), run by AbbVie at 16 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Read more about this study

Who is it for?
Any age
What is being tested?
Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
16 sitesUnited States
Study dates
20 Dec 2021to Jul 2031
Phase
Phase 2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Must provide written, signed informed consent for this study.
  • Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study.
  • Must be willing and able to comply with all study procedures.

Who cannot join

  • 1. None

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

United States16 sites

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Southeast Retina Center PC

    Augusta, Georgia, 30909

  • California Retina Consultants

    Bakersfield, California, 93309

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Vitreoretinal Surgery PLLC

    Edina, Minnesota, 55435

  • Charles Retina Institute, P.C

    Germantown, Tennessee, 38138

  • Northern California Retina Vitreous Associates Medical Group Inc

    Mountain View, California, 94040

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • Retinovitreous Associates, LTD

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Retina Consultants San Diego

    Poway, California, 92064

  • Sierra eye Associates

    Reno, Nevada, 89502

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

Other trials in United States

About this study

Official title: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration

This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.

Being tested
Standard of Care, Ranibizumab
Keywords
Gene Therapy, AMD, wet AMD, wAMD, nAMD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of CareDrug

    Standard of Care

  • RanibizumabDrug

    Also called LUCENTIS

    Injection

Study groups in NCT05210803
Study groupRoleWhat they receive
Standard of CareOtherDose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration.
Receives: Drug: Standard of Care
Supplemental TreatmentOtherDL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.
Receives: Drug: Standard of Care; Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidences of ocular Adverse Events and any Serious Adverse Events

    To evaluate the long-term safety of ABBV-RGX-314

    Measured: 5 years inclusive of parent study

Secondary outcomes (9)

  1. Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest

    To evaluate the long-term safety of ABBV-RGX-314

    Measured: 5 years inclusive of parent study

  2. Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA based on ETDRS score in the study eye at assessed timepoints

    To evaluate the persistence of effect of ABBV-RGX-314 on best corrected visual acuity (BCVA)

    Measured: 5 years inclusive of parent study

  3. Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints

    To evaluate the persistence of effect of ABBV-RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)

    Measured: 5 years inclusive of parent study

  4. Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5

    To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy

    Measured: 5 years inclusive of parent study

  5. Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5

    To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy

    Measured: 5 years inclusive of parent study

  6. Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5

    To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy

    Measured: 5 years inclusive of parent study

  7. Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5

    To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy

    Measured: 5 years inclusive of parent study

  8. Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5

    To assess the need of clinic visits for management of nAMD

    Measured: 5 years inclusive of parent study

  9. Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5

    To assess the need of clinic visits for management of nAMD

    Measured: 5 years inclusive of parent study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start20 Dec 2021
  3. Primary completionJul 2031 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05210803
Sponsor's protocol ID
RGX-314-5102 (M23-421)
Other IDs
M23-421
Status last verified
Aug 2026
First submitted
14 Jan 2022
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ranibizumab in people with Neovascular Age-Related Macular Degeneration (nAMD), run by AbbVie at 16 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 3 inclusion and 1 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: enrolling by invitation, 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 16 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?

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?

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?

Incidences of ocular Adverse Events and any Serious Adverse Events (time frame: 5 years inclusive of parent study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05210803.

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.

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