NCT05986864 · Skyline Therapeutics (US) Inc.
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
What this study is about
This is a phase 1/2 clinical study to evaluate the safety, preliminary effectiveness, immunogenicity, and how the drug moves through the body (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 gradually increasing doses study, the phase 2 expansion study will be conducted.
View original scientific description
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.
Interventions
GENETIC
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Primary outcome measures
Characteristics of dose limiting toxicities (DLTs)
Time frame: 4 Weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Time frame: 52 Weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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; 2. Aged ≥ 50 years at screening; Study Eye: 3. Diagnosis of nAMD as determined by the PI; 4. Active CNV lesions secondary to age-related macular degeneration (AMD); 5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment.
Exclusion criteria
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline; 2. Retinal pigment epithelial tear in the study eye at screening; 3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline; 4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye; 5. History of retinal det
Where
- St. Petersburg, Florida
- Boston, Massachusetts
- Katy, Texas
- Norfolk, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2025 · Source of record for eligibility and locations