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New treatment option for Neovascular Age-related Macular Degeneration
Official title Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
ClinicalTrials.gov ID: NCT05986864
What this study is testing
What is SKG0106?
SKG0106 is an investigational 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 is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
- 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 and older
You may be able to join if
- 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;
- Aged ≥ 50 years at screening; Study Eye:
- Diagnosis of nAMD as determined by the PI;
- Active CNV lesions secondary to age-related macular degeneration (AMD);
- people must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment.
You likely can't join if
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis...
- Retinal pigment epithelial tear in the study eye at screening;
- Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
- Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
- History of retinal detachment or active retinal detachment in the study eye;
- Any prior gene therapy.
The study team makes the final eligibility decision.
Where it's taking place
- St. Petersburg, Florida, United States
- Boston, Massachusetts, United States
- Katy, Texas, United States
- Norfolk, Virginia, United States
- Hefei, Anhui, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
- Beijing, 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 St. Petersburg, Florida, United States; Boston, Massachusetts, United States; Katy, Texas, United States; Norfolk, Virginia, United States; Hefei, Anhui, China; Hangzhou, Zhejiang, China and 2 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.