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NCT05643118
Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration
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.
25 November 2024
Quick facts
| Lead sponsor | Olix Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 4 January 2023 |
| Primary completion | 25 November 2024 |
| Estimated completion | 10 November 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)
Conditions studied
- Neovascular Age-related Macular Degeneration — all drugs for Neovascular Age-related Macular Degeneration →
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):
-
Current Approaches to Epigenetic Therapy.
Griazeva ED, Fedoseeva DM, Radion EI, Ershov PV, et al · · 2023 · cited 11× · PMID 37873808 · DOI 10.3390/epigenomes7040023 -
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 -
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 -
Therapeutic siRNA: Mechanisms, challenges, strategies, and clinical translation.
Jiang Q, Fu J, An Y, Liu Y. · · 2026 · PMID 42036903 · DOI 10.1097/cm9.0000000000004061 -
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:
- PubMed search for NCT05643118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neovascular Age-related Macular Degeneration
Currently open trials in the same condition.
- NCT07275840 — A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD · Phase 2 · recruiting
- NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD · Phase 3 · recruiting
- NCT07053358 — Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients · EARLY_PHASE1 · recruiting
- NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
- NCT06495918 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- R · Phase 3 · active not recruiting
Other Olix Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT04877756 — Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery · Phase 2 · completed
- NCT03569267 — A Study to Evaluate Safety and PK Profiles of OLX10010 in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05643118 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Olix Pharmaceuticals, Inc.
- Last refreshed: 11 December 2025
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