NCT01739244

Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma

Completed Phase 2 Last updated 7 June 2013

What this trial tests

Phase 2 trial testing SYL040012 in Ocular Hypertension in 80 participants. Completed in 1 May 2013.

Timeline

1 July 2012

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Sylentis, S.A.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	1 July 2012
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	11 locations across Estonia, Germany, Spain

Drugs / interventions tested

• SYL040012 — full drug profile →
• Placebo

Conditions studied

• Ocular Hypertension — all drugs for Ocular Hypertension →
• Open Angle Glaucoma — all drugs for Open Angle Glaucoma →

Sponsor

Sylentis, S.A. — full company profile →

Who can join

18 and older, any sex, with Ocular Hypertension or Open Angle Glaucoma. 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.

• Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
  Time frame: 14 days + (4-7 days)
• Simple Corneal and Conjunctival Evaluation
  Time frame: 15 days + (3-6 days)

Sponsor's own description

The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local tolerability and intraocular pressure lowering effect of three different doses of SYL040012 in subjects with ocular hypertension or open-angle glaucoma.

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. Clinical Translation of Nanomedicine.
   Min Y, Caster JM, Eblan MJ, Wang AZ. · · 2015 · cited 495× · PMID 26088284 · DOI 10.1021/acs.chemrev.5b00116
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. RNAi therapies: drugging the undruggable.
   Wu SY, Lopez-Berestein G, Calin GA, Calin GA, et al · · 2014 · cited 195× · PMID 24920658 · DOI 10.1126/scitranslmed.3008362
6. Nanotoxicity: a key obstacle to clinical translation of siRNA-based nanomedicine.
   Xue HY, Liu S, Wong HL. · · 2014 · cited 179× · PMID 24552562 · DOI 10.2217/nnm.13.204
7. Therapeutic nucleic acids: current clinical status.
   Sridharan K, Gogtay NJ. · · 2016 · cited 153× · PMID 27111518 · DOI 10.1111/bcp.12987
8. Engineering functional inorganic-organic hybrid systems: advances in siRNA therapeutics.
   Shen J, Zhang W, Qi R, Mao ZW, et al · · 2018 · cited 91× · PMID 29417968 · DOI 10.1039/c7cs00479f