Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD

NCT01021956 | Terminated Phase 2 Results

• 1 other identifier: CLIN905 MLT202
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 4

Brief Summary

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).

Conditions

Macular Degeneration; Choroidal Neovascularization

Keywords

Macular Degeneration; Age Related Macular Degeneration; Choroidal Neovascularization; AMD; CNV; WST11; Stakel; Photodynamic therapy; Vascular Targeted Photodynamic therapy; VTP

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs) - Number of Subjects With Eye Disorders

  Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.

  12 week follow-up

Secondary Outcomes (1)

• Visual Acuity

  Week 12.

Study Arms (1)

WST11 (STAKEL)

EXPERIMENTAL

Single doses of 2.5 mg/kg of STAKEL® in combination with transpupilar illumination of the macula at escalating doses from 12.5 to 75 Joules/cm².

Drug: STAKEL

Interventions

STAKEL DRUG

Open-label,safety and exploratory efficacy study in subjects with active CNV followed for 12 weeks.During first stage(dose escalating stage) subjects assigned to group 1 to 4 will receive a single treatment of VTP at one of three light levels and one of two Drug Light Interval (DLI).Second stage(dose confirmation)will be only initiated at a dose level in which an effect has been seen at week 1 and there is a maximum of one Dose Limiting Toxicity (DLT) out of three subject at week 5.

Also known as: WST11

WST11 (STAKEL)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty eight days or more after at least one ranibizumab injection, recurrent leakage on Fluorescein Angiography (FA) from subfoveal Choroidal NeoVessels (CNV) secondary to AMD.
• Total lesion size not exceeding 5400 μm in its greatest linear dimension.
• Best Corrected Visual Acuity (BCVA) letter score of 73 to 23 in the study eye at a starting distance of 4 meters.
• No contraindication to intravitreal ranibizumab injection.
• Postmenopausal for at least 12 months prior to enrollment or practicing medically acceptable form of birth control and not pregnant. Male subjects must be practicing a medically acceptable form of birth control.

You may not qualify if:

• Prior treatments:
• Previous subfoveal laser photocoagulation, external-beam radiation therapy, or transpupillary thermoTherapy (TTT) in the study eye at any time.
• Using anti-VEGF therapies for other indications (e.g., cancer) in the 30 days prior to the study and/or during the study
• Received anti-VEGF injection in study eye during less than 28 days prior to Day 1 of the study.
• More than three previous photodynamic therapy (PDT) treatments in the preceding 12 months.
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within the preceding month.
• History of vitrectomy,of glaucoma filtering surgery,submacular surgery or other surgical intervention in the study eye.
• History of corneal transplant in the study eye.
• Previous participation in any studies of investigational drugs within 1 month preceding Day 1 (excluding vitamins and minerals).
• Lesion Characteristics
• Permanent structural damage to the center of the fovea of the study eye, or a concurrent ocular or systemic condition that could contraindicate administration of an investigational drug, or render the subject at a high risk of treatment complications.
• Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥50% of the total lesion area or ≥1 disc area in size.
• Subfoveal fibrosis or atrophy in the study eye which is at least 50% of the lesion.
• CNV in either eye due to other causes.
• Retinal pigment epithelial tear involving the macula in the study eye.

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (4)

Johns Hopkins,Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Valley Retina Institute

Harlingen, Texas, 78550, United States

Location

Hotel Dieu de Paris Hospital

Paris, 75004, France

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

padeliporfin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bertrand Gaillac International Project Leader
• Organization: STEBA Biotech

b.gaillac@stebabiotech.com

+33 9 74 19 79 05

Study Officials

• Neil Bressler, Professor

  Johns Hopkins University

  STUDY CHAIR

• Victor Gonzalez, Professor

  Valley Retina Institute

  PRINCIPAL INVESTIGATOR

• John Wells, Professor

  Palmetto Retina Center

  PRINCIPAL INVESTIGATOR

• Francine Behar Cohen, Professor

  Hotel Dieu Hospital

  PRINCIPAL INVESTIGATOR

• Adrienne Scott, Doctor

  Johns Hopkins/ Wilmer Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2009
• First Posted: December 1, 2009
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: January 1, 2014
• Last Updated: September 17, 2018
• Results First Posted: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (3)