BridgeMD
Tests treatment safety and results for Age-related Macular Degeneration
Official title Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
ClinicalTrials.gov ID: NCT06458595
What this study is testing
What is KH658?
KH658 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for 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
- KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Are willing and able to sign the informed consent form (ICF);
- Female and male aged 50 to 85 years (inclusive) with nAMD;
- Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in...
- Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
- Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
You likely can't join if
- Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator...
- Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
- Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye...
- Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
- Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
- Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
See the full eligibility criteria
- Are willing and able to sign the informed consent form (ICF);
- Female and male aged 50 to 85 years (inclusive) with nAMD;
- Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening;
- Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
- Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
- Females must be at least 1 year postmenopausal.
- Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as...
- Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
- Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening;
- Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
- Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
- Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. 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.