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NCT05986864 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

A Phase 1 study of Neovascular Age-related Macular Degeneration, sponsored by Skyline Therapeutics (US).

Recruiting
Registry status
Phase 1
Development phase
68
Enrollment target
9
Study locations

NCT05986864 is a Phase 1 study of Neovascular Age-related Macular Degeneration that is actively recruiting participants, run by Skyline Therapeutics (US). The registered enrollment target is 68 participants, below the 407-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (83% lower). The trial reports 9 study locations across 7 states.

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The verdict

NCT05986864, a Phase 1 study of Neovascular Age-related Macular Degeneration, is actively recruiting participants, sponsored by Skyline Therapeutics (US).

RECRUITING
Registry status
Phase 1
Development phase
68 participants
Enrollment target
9
Study locations

Study Summary

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.

Conditions Studied

Neovascular Age-related Macular Degeneration

Interventions

  • GENETIC SKG0106

Study Locations (9)

Zhejiang

  • Zhejiang Provincial People's Hospital - Hangzhou
  • Eye Hospital, WMU (Zhejiang Eye Hospital) - Wenzhou

Other

  • Beijing Hospital - Beijing
  • Peking Union Medical College Hospital - Beijing

Florida

  • Retina Vitreous Associates of Florida - Saint Petersburg - St. Petersburg

Massachusetts

  • Ophthalmic Consultants of Boston - Boston

Texas

  • Retina Consultants of Texas - Katy

Virginia

  • Wagner Kapoor Research Institute - Norfolk

Anhui

  • The Second Hospital Of Anhui Medical University - Hefei

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2024-02-23
Est. Completion 2026-01-30
Phase Phase 1

Sponsor

Skyline Therapeutics (US)

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05986864

The ClinicalTrials.gov registry entry for NCT05986864 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (83% lower). The listed sponsor is Skyline Therapeutics (US), which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which SKG0106 is the first listed.

NCT05986864 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Zhejiang, Other, Florida.

Frequently Asked Questions

What is clinical trial NCT05986864 about?

NCT05986864 is a clinical study titled "Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)". 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.

What is the current status of trial NCT05986864?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2024-02-23. Estimated completion is 2026-01-30.

What conditions does trial NCT05986864 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.

What interventions are being tested in trial NCT05986864?

The interventions under investigation include: SKG0106 (GENETIC).

Who is sponsoring clinical trial NCT05986864?

This trial is sponsored by Skyline Therapeutics (US), which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05986864 being conducted?

This trial has 9 study locations across Florida, Massachusetts, Texas, Virginia, Anhui. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.