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NCT Number: NCT04246866

First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration

The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.

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Key information

Conditions

Dry Age-related Macular Degeneration Eye Diseases Eye Diseases, Hereditary Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Disease Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Associated Retina Consultants, Phoenix, Arizona, United States

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About this study

This is a Phase 1, multicenter, open-label, single-dose, dose-escalation study in subjects with GA secondary to dry AMD to investigate the safety, tolerability, pharmacodynamics (PD), and immunogenicity of IVT injections of GEM103 to a single eye.

The study is designed to identify the MTD for IVT administration of GEM103. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of DLTs. Three escalating dose cohorts are planned.

Subjects will undergo clinical and ophthalmic assessments for inclusion eligibility into the study. Enrolled subjects will receive GEM103 and be followed for safety, PK, clinical, and biomarker evaluations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 50 years old at the time of signed informed consent
  • Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure
  • Best corrected visual acuity (BCVA) in study eye between 5-45 letters
  • Confirmed diagnosis of central GA in the study eye and eligible total GA lesion size

Exclusion criteria

  • Presence of the following ocular conditions - in the study eye:
  • Exudative AMD or choroidal neovascularization (CNV)
  • Any ocular disease or condition that could impact the subject's ability to participate in the study or be a contraindication to IVT injection
  • Any intraocular surgery (with the exception of intraocular lens replacement surgery more than 3 months prior to consent)
  • Presence of any of the following ocular conditions - in either eye:
  • History of herpetic infection
  • Ongoing treatment with antiangiogenic therapies in the fellow eye or completed treatment in the study eye
  • Any prior or ongoing medical condition (e.g. ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
  • Female subjects must not be pregnant or lactating
  • Current use of medications known to be toxic to the lens, retina, or optic nerve

Treatment and study plan

GEM103

Biological

GEM103

Primary outcomes

  1. Incidence and severity of AEs/SAEs following drug administration

    Time frame: Up to 8 Weeks

Secondary outcomes

  1. GEM103 concentrations in ocular fluids

    Time frame: Up to 8 Weeks

  2. Changes in complement factor levels compared to baseline after drug administration

    Time frame: Up to 8 Weeks

Other outcomes

  1. Change from baseline in aqueous humor biomarker levels (in ng/mL) of complement factors

    Time frame: Up to 8 Weeks

  2. Change from baseline in clinical assessments including BCVA and LLVA scores as assessed by ETDRS Visual Acuity Score in number of letters

    Time frame: Up to 8 Weeks

  3. Change from baseline in clinical assessments including area of GA in mm2 as assessed by fundus imaging

    Time frame: Up to 8 Weeks

  4. Change in concentration of GEM103 in blood samples

    Time frame: Up to 8 Weeks

Sponsors and collaborators

Lead sponsor

Gemini Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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