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

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.

Conditions

Neovascular Age-related Macular Degeneration

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Study Overview

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Study Details

Study overview

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 I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

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

Condition
Neovascular Age-related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Boston

Ophthalmic Consultants of Boston, Boston, Massachusetts, United States, 02114

Katy

Retina Consultants of Texas, Katy, Texas, United States, 77494

Norfolk

Wagner Kapoor Research Institute, Norfolk, Virginia, United States, 23502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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;
  • 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.
  • 1. 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 detachment or active retinal detachment in the study eye;
  • 6. Any prior gene therapy.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Skyline Therapeutics (US) Inc.,

Study Record Dates

2026-01-30