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NCT05643118

Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration

Completed Phase 1 Last updated 11 December 2025
What this trial tests

Phase 1 trial testing OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) in Neovascular Age-related Macular Degeneration in 21 participants. Completed in 10 November 2025.

Timeline
4 January 2023
Primary endpoint
25 November 2024
10 November 2025

Quick facts

Lead sponsorOlix Pharmaceuticals, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment21
Start date4 January 2023
Primary completion25 November 2024
Estimated completion10 November 2025
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Olix Pharmaceuticals, Inc. — full company profile →

Who can join

50 and older, any sex, with Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD. The exploratory objectives are to evaluate the preliminary efficacy of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD, and to evaluate the pharmacokinetics (PK) of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current Approaches to Epigenetic Therapy.
    Griazeva ED, Fedoseeva DM, Radion EI, Ershov PV, et al · · 2023 · cited 11× · PMID 37873808 · DOI 10.3390/epigenomes7040023
  2. Advances in locally administered nucleic acid therapeutics.
    Shen J, Duan X, Xie T, Zhang X, et al · · 2025 · cited 5× · PMID 40144794 · DOI 10.1016/j.bioactmat.2025.02.043
  3. Nanomaterial-Based Anti-Angiogenic Gene Therapy for Retinal Neovascular Diseases: Mechanistic Insights and Preclinical Advances.
    Zeng L, Wei Y, Qiu Y, Bi R, et al · · 2025 · cited 1× · PMID 40989889 · DOI 10.2147/ijn.s521960
  4. Therapeutic siRNA: Mechanisms, challenges, strategies, and clinical translation.
    Jiang Q, Fu J, An Y, Liu Y. · · 2026 · PMID 42036903 · DOI 10.1097/cm9.0000000000004061
  5. Can MicroRNAs serve as reliable biomarkers and novel therapeutic targets in age-related macular degeneration? A systematic review and meta-analysis.
    Chen KY, Chan HC, Chan CM. · · 2026 · PMID 41680791 · DOI 10.1186/s12967-025-07593-x

Verify or expand the search:

Other recruiting trials for Neovascular Age-related Macular Degeneration

Currently open trials in the same condition.

Other Olix Pharmaceuticals, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05643118.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing