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Tests treatment safety and results for Neovascular Age-related Macular Degeneration
Official title A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)
ClinicalTrials.gov ID: NCT05562947
What this study is testing
What is Ranibizumab (10 mg/mL)?
Ranibizumab (10 mg/mL) is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for neovascular age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Chengdu, China
- Guangzhou, China
- Harbin, China
- Qingdao, China
- Shanghai, China
- Shenyang, China
- Taiyuan, China
- Tianjin, China
- Wenzhou, China
- Wuhan, China
- Xi'an, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Chengdu, China; Guangzhou, China; Harbin, China; Qingdao, China; Shanghai, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.