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Eye implant could replace monthly shots for blinding disease

NCT ID NCT05562947

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This study tests a small, refillable implant placed in the eye that slowly releases medication for wet age-related macular degeneration (nAMD). It aims to see if refilling the implant every 24 weeks works as well as getting a standard eye injection every 4 weeks. About 68 Chinese patients who have already responded to standard treatment will take part. The main goal is to measure changes in vision over time.

What this could mean

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

Active substance
ranibizumab delivered via a refillable eye implant (Port Delivery System)
What this could lead to
If successful, this implant could allow patients with wet AMD to receive treatment every 6 months instead of monthly injections, reducing clinic visits.
What could go wrong
This is a Phase 3 trial with only 68 participants, so results may not apply to all patients. The implant requires surgery and carries risks like infection or implant issues.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 68 people

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

Started

Jun 2024

Expected to finish

Jul 2029

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: * Initial diagnosis of nAMD within 9 months prior to the screening visit * Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard-of-care (SOC) within 6 months prior to the screening visit * Demonstrated response to prior anti-VEGF IVT treatment since diagnosis * Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit * BCVA of 34 letters or better (20/200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters * All subtypes of nAMD lesions are permissible * Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images Exclusion Criteria: A. Prior Ocular Treatment Study Eye * History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD * Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy * Previous treatment with corticosteroid IVT injection or corticosteroid implants * Previous intraocular device implantation (not including intraocular lens implants) * Previous laser (any type) used for age-related macular degeneration (AMD) treatment * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit * Prior treatment with IVT treatments for geographic atrophy * Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant Either Eye * Prior treatment with brolucizumab * Prior gene therapy for nAMD or other ocular diseases * Previous participation in any ocular disease studies of investigational drugs and/or devices, within 3 months or five elimination half-lives of the investigational therapy, whichever is longer, preceding the screening visit B. Choroidal Neovascularization (CNV) Lesion Characteristics Study Eye * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 millimeter square \[mm\^2\]) in size at screening * Subfoveal fibrosis or subfoveal atrophy Either Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia C. Concurrent Ocular Conditions Study Eye * Retinal pigment epithelial tear * Any concurrent intraocular condition * Active intraocular inflammation (grade trace or above) * History of vitreous hemorrhage * History of rhegmatogenous retinal detachment * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the randomization visit * History of pars plana vitrectomy surgery * Aphakia or absence of the posterior capsule * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery * Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit * Uncontrolled ocular hypertension or glaucoma * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * History of corneal transplant Fellow (Non-Study) Eye • Non-functioning fellow eye Either Eye * Any history of uveitis * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Beijing Tongren Hospital

    Beijing, 100730, China

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027, China

  • Peking Union Medical College Hospital

    Beijing, 100032, China

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 266109, China

  • Shanghai First People's Hospital

    Shanghai, 200080, China

  • Shanxi Eye Hospital

    Taiyuan, 030002, China

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • The First Affiliated Hospital of China Medical University

    Shenyang, 110001, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, 150081, China

  • Tianjin Medical University Eye Hospital

    Tianjin, 300070, China

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an, China

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060, China

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