NCT01021956 is a Phase 2 clinical trial of STAKEL in Macular Degeneration, sponsored by Steba Biotech S.A..

Who is sponsoring NCT01021956?

NCT01021956 is sponsored by Steba Biotech S.A..

What drugs are being tested in NCT01021956?

Interventions in NCT01021956: STAKEL.

What condition does NCT01021956 study?

NCT01021956 studies Macular Degeneration, Choroidal Neovascularization.

Is NCT01021956 still recruiting?

NCT01021956 is currently terminated. Last updated 13 September 2018.

Are results published for NCT01021956?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-09-13 · How we verify

NCT01021956

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®) Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects With Choroidal Neovascularization (CNV) Associated With Age-Related Macular Degeneration (AMD)

Terminated Phase 2 Results posted Last updated 13 September 2018

What this trial tests

Phase 2 trial testing STAKEL in Macular Degeneration in 10 participants. Terminated before completion.

Timeline

1 June 2010

Primary endpoint
1 May 2012

1 January 2014

Quick facts

Lead sponsor	Steba Biotech S.A.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 June 2010
Primary completion	1 May 2012
Estimated completion	1 January 2014
Sites	4 locations across United States, France

Drugs / interventions tested

STAKEL — full drug profile →

Conditions studied

Macular Degeneration — all drugs for Macular Degeneration →
Choroidal Neovascularization — all drugs for Choroidal Neovascularization →

Sponsor

Steba Biotech S.A. — full company profile →

Who can join

50 and older, any sex, with Macular Degeneration or Choroidal Neovascularization. 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.

Adverse Events (AEs) - Number of Subjects With Eye Disorders
Time frame: 12 week follow-up
Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.

Sponsor's own description

The objectives of this study are to evaluate the safety(first objective) and efficacy(second objective)of an experimental drug product,Stakel®, in the treatment of neovascular Age related Macular Degeneration (AMD). The drug product is activated in patients by exposure to light at a specific wavelength ("Vascular Targeted Photodynamic therapy", "VTP"). The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti Vascular Endothelium Growth Factor (anti VEGF) intravitreal therapy in the first 12 weeks after VTP. All subjects will have a 52 weeks safety follow up telephone call (Not for Adverse Events (AEs) collection).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Macular Degeneration

Currently open trials in the same condition.

NCT07440225 — A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) · Phase 2, PHASE3 · recruiting
NCT07085533 — Natural History Study of Inherited Retinal Diseases · recruiting
NCT06805474 — A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT · recruiting
NCT06779773 — A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy · recruiting
NCT06635148 — A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Se · Phase 2 · recruiting

Other Steba Biotech S.A. trials

Trials by the same sponsor.

NCT04620239 — ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study · Phase 3 · recruiting
NCT04225299 — Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer · Phase 3 · withdrawn
NCT03849365 — Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer · Phase 4 · terminated
NCT03315754 — Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. · Phase 2 · active not recruiting
NCT04017325 — European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01021956 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Steba Biotech S.A.
Last refreshed: 13 September 2018

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/NCT01021956.

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