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

This study has been terminated.
(As two cases of retinal vascular occlusion in patients who received anti-VEGF)
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.
ClinicalTrials.gov Identifier:
NCT01021956
First received: November 29, 2009
Last updated: April 27, 2015
Last verified: April 2015

November 29, 2009
April 27, 2015
June 2010
May 2012   (final data collection date for primary outcome measure)
Safety assessments include recording of all complications and AEs, loss of lines in BCVA, slit lamp findings, IOP, and fundus findings. All ocular and non-ocular AEs must be assessed for severity and relationship to the investigational product. [ Time Frame: Day 1;Week 1;Week 5;Week 12. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01021956 on ClinicalTrials.gov Archive Site
  • Percentage of neovessels occlusion(FA and ICGA)expressed in percentage of the baseline area and outcomes of BCVA measurement, fundus photographs, OCT, number of ranibizumab injections and time to rescue therapy. [ Time Frame: Day 1; Week 1; Week 5; Week 12. ] [ Designated as safety issue: No ]
  • Safety follow up [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
    All subjects will have a 52 weeks safety follow up telephone call.
Percentage of neovessels occlusion(FA and ICGA)expressed in percentage of the baseline area and outcomes of BCVA measurement, fundus photographs, OCT, number of ranibizumab injections and time to rescue therapy. [ Time Frame: Day 1; Week 1; Week 5; Week 12. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
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)

The objectives of this study is to evaluate the safety(first objective) and efficacy(second objective)of an experimental drug product,Stakel®, in the treatment of neovascular 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 VEGF intravitreal therapy in the first 12 weeks after VTP.

All subjects will have a 52 weeks safety follow up telephone call.

The primary objective of this Phase IIa clinical study is to evaluate the safety of treatment with Stakel®-mediated VTP in subjects with neovascular AMD. The secondary objective of this Phase IIa clinical study is to explore the effect of treatment with Stakel®-mediated VTP in subjects with neovascular AMD. The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti VEGF intravitreal therapy in the first 12 weeks after VTP.

All subjects will have a 52 weeks safety follow up telephone call.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Macular Degeneration
  • Choroidal Neovascularization
Drug: STAKEL
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 DLI.Second stage(dose confirmation)will be only initiated at a dose level which an effect has been seen at week 1 and there is no DLT at week 5.
Other Name: WST11
Experimental: WST11 (STAKEL)
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.
Intervention: Drug: STAKEL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
January 2014
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Twenty eight days or more after at least one ranibizumab injection, recurrent leakage on FA from subfoveal 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.

Exclusion Criteria:

  • 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.
  • Concurrent Ocular Conditions

    • Active intraocular inflammation (grade trace or above) or current vitreous hemorrhage or rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
    • History of idiopathic or autoimmune-associated uveitis in either eye.
    • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
    • Aphakia or absence of the posterior capsule in the study eye.
    • Spherical equivalent of the refractive error in the study eye demonstrating more-than eight diopters of myopia.
    • Intraocular surgery (including cataract surgery) in the study eye within three months preceding Day 1.
    • Uncontrolled glaucoma in the study eye.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01021956
CLIN905 MLT202
No
Steba Biotech S.A.
Steba Biotech S.A.
Not Provided
Study Chair: Neil Bressler, Professor Johns Hopkins University
Principal Investigator: 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
Steba Biotech S.A.
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP