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Can a One-Time gene injection ease the burden of wet AMD?

NCT ID NCT05986864

Disease control Sponsor: Skyline Therapeutics (US) Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This phase 1/2 trial tests SKG0106, a gene therapy injected into the eye, in people with wet age-related macular degeneration (nAMD). The treatment aims to help the eye produce proteins that block abnormal blood vessel growth, potentially reducing the need for frequent anti-VEGF injections. Researchers will evaluate safety, tolerability, and early signs of effectiveness, such as changes in vision and retinal thickness. The study includes adults aged 50 and older who have responded to prior anti-VEGF therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SKG0106, a gene therapy delivered by a virus vector into the eye
What this could lead to
If it works, SKG0106 could offer a longer-lasting treatment for wet AMD, potentially reducing the need for frequent eye injections and preserving vision.
What could go wrong
This is an early-phase trial with a small number of participants. The gene therapy may not be effective or could cause side effects like inflammation or infection. Long-term safety and durability are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol; 2. Aged ≥ 50 years at screening; Study Eye: 3. Diagnosis of nAMD as determined by the PI; 4. Active CNV lesions secondary to age-related macular degeneration (AMD); 5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment. Exclusion Criteria: 1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline; 2. Retinal pigment epithelial tear in the study eye at screening; 3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline; 4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye; 5. History of retinal detachment or active retinal detachment in the study eye; 6. Any prior gene therapy.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Hospital

    RECRUITING

    Beijing, China

  • Eye Hospital, WMU (Zhejiang Eye Hospital)

    RECRUITING

    Wenzhou, Zhejiang, China

  • Ophthalmic Consultants of Boston

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Retina Consultants of Texas

    RECRUITING

    Katy, Texas, 77494, United States

  • Retina Vitreous Associates of Florida - Saint Petersburg

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33711, United States

  • The Second Hospital Of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • Wagner Kapoor Research Institute

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

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