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NCT02250612: SYLTAG

A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension

Completed Phase 2 Results posted Last updated 11 December 2020
What this trial tests

Phase 2 trial testing 1 drop of 0.375% SYL040012 (bamosiran) in Open Angle Glaucoma in 184 participants. Completed in 1 January 2016.

Timeline
1 October 2014
Primary endpoint
1 August 2015
1 January 2016

Quick facts

Lead sponsorSylentis, S.A.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment184
Start date1 October 2014
Primary completion1 August 2015
Estimated completion1 January 2016
Sites21 locations across United States, Estonia, Germany, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Sylentis, S.A. — full company profile →

Who can join

18 and older, any sex, with Open Angle Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.

Publications & conference data

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

  1. Noncoding RNA therapeutics - challenges and potential solutions.
    Winkle M, El-Daly SM, Fabbri M, Calin GA. · · 2021 · cited 1123× · PMID 34145432 · DOI 10.1038/s41573-021-00219-z
  2. Therapeutic siRNA: state of the art.
    Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x
  3. Advances in the delivery of RNA therapeutics: from concept to clinical reality.
    Kaczmarek JC, Kowalski PS, Anderson DG. · · 2017 · cited 467× · PMID 28655327 · DOI 10.1186/s13073-017-0450-0
  4. Preclinical and clinical development of siRNA-based therapeutics.
    Ozcan G, Ozpolat B, Coleman RL, Sood AK, et al · · 2015 · cited 331× · PMID 25666164 · DOI 10.1016/j.addr.2015.01.007
  5. Therapeutic siRNA: State-of-the-Art and Future Perspectives.
    Friedrich M, Aigner A. · · 2022 · cited 256× · PMID 35997897 · DOI 10.1007/s40259-022-00549-3
  6. Paving the Road for RNA Therapeutics.
    Dammes N, Peer D. · · 2020 · cited 159× · PMID 32893005 · DOI 10.1016/j.tips.2020.08.004
  7. Therapeutic nucleic acids: current clinical status.
    Sridharan K, Gogtay NJ. · · 2016 · cited 153× · PMID 27111518 · DOI 10.1111/bcp.12987
  8. The landscape of nanoparticle-based siRNA delivery and therapeutic development.
    Moazzam M, Zhang M, Hussain A, Yu X, et al · · 2024 · cited 116× · PMID 38204162 · DOI 10.1016/j.ymthe.2024.01.005

Verify or expand the search:

Other recruiting trials for Open Angle Glaucoma

Currently open trials in the same condition.

Other Sylentis, S.A. 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/NCT02250612.

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