Eye implant could replace monthly shots for blinding disease
NCT ID NCT05562947
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Beijing Tongren Hospital
Beijing, 100730, China
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Eye Hospital, Wenzhou Medical University
Wenzhou, 325027, China
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Peking Union Medical College Hospital
Beijing, 100032, China
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Qingdao Eye Hospital of Shandong First Medical University
Qingdao, 266109, China
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Shanghai First People's Hospital
Shanghai, 200080, China
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Shanxi Eye Hospital
Taiyuan, 030002, China
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Sichuan Provincial People's Hospital
Chengdu, 610072, China
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The First Affiliated Hospital of China Medical University
Shenyang, 110001, China
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The Second Affiliated Hospital of Harbin Medical University
Harbin, 150081, China
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Tianjin Medical University Eye Hospital
Tianjin, 300070, China
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Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030, China
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West China Hospital, Sichuan University
Chengdu, 610041, China
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Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, China
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer eye injections dry the retina in wet AMD?
- The 20-Minute squeeze: how eye injections push pressure up
- Could years of eye injections weigh down the upper eyelid?
- One shot in the eye: gene therapy aims to replace repeated injections for wet AMD
- Can a One-Time gene injection ease the burden of wet AMD?
- Longer-Lasting eye injection could cut treatment visits for macular disease