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Monoclonal Antibodies
SKG0106 for Age-Related Macular Degeneration
Phase 1 & 2
Recruiting
Research Sponsored by Skyline Therapeutics (US) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will evaluate the safety & efficacy of SKG0106, a drug for treating nAMD, compared to Eylea® in a double-masked study.
Who is the study for?
This trial is for individuals aged 50 or older with neovascular Age-related Macular Degeneration (nAMD). Participants must have a specific type of lesion in the eye and some fluid in the retina, with vision levels within a certain range. They cannot join if they have any active eye infections, certain types of retinal damage, recent vitreous hemorrhage, conditions that limit vision improvement, history of gene therapy or retinal detachment.Check my eligibility
What is being tested?
The study tests SKG0106 intraocular solution's safety and effectiveness for nAMD patients. It starts with determining safe dosage levels (Phase I) and then expands to more patients to further assess its effects (Phase II), including how long it stays in the body and if it triggers immune responses.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions related to intraocular injections such as eye irritation or inflammation, increased risk of infection inside the eye, possible allergic reactions to components of SKG0106 solution.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characteristics of dose limiting toxicities (DLTs)
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Secondary outcome measures
Mean change from baseline in best corrected visual acuity (BCVA) at each visit
Mean change from baseline in central subfield thickness (CST) at each visit
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase I: Medium doseExperimental Treatment1 Intervention
SKG0106 One-Time Intraocular Injection Dose Level 2
Group II: Phase I: Low doseExperimental Treatment1 Intervention
SKG0106 One-Time Intraocular Injection Dose Level 1
Group III: Phase I: High doseExperimental Treatment1 Intervention
SKG0106 One-Time Intraocular Injection Dose Level 3
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Who is running the clinical trial?
Skyline Therapeutics (US) Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tear in the retina of my study eye.I have had or currently have a detached retina in my study eye.My previous treatment for cancer, which targeted blood vessel growth, was effective.I do not have any active eye infections or inflammation.I have a condition that might prevent my vision from getting better in the study.I can sign a consent form and follow the study's requirements.I have had bleeding inside my eye recently or now.I am 50 years old or older.I have been diagnosed with wet age-related macular degeneration.I have had gene therapy before.I have active vision loss due to AMD.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: Medium dose
- Group 2: Phase I: Low dose
- Group 3: Phase I: High dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for the ongoing clinical trial?
"Clinicaltrials.gov states that this trial, posted on March 31st 2023 and last updated August 3rd 2023, is not actively searching for participants. Nevertheless, there are presently 174 other trials recruiting patients at the moment."
Answered by AI
What are the primary goals of this medical trial?
"The primary outcome of this medical trial, evaluated for a full year, is to improve BCVA. A few secondary objectives include SD-OCT measurements of CSTQuestionnaire-25 (VFQ-25), ICG assessment in the study eye at screening, and post-treatment VFQ evaluation."
Answered by AI
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