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

This study has suspended participant recruitment.
(Following two incidents occurred at higher energy dose levels,no further patient should be entered until further information is available.)
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.
ClinicalTrials.gov Identifier:
NCT01021956
First received: November 29, 2009
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Choroidal Neovascularization
Drug: WST11 (STAKEL)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Steba Biotech S.A.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 18
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WST11 (STAKEL) Drug: WST11 (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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Twenty eight days or more after at least one ranibizumab injection, recurrent leakage on FA from subfoveal CNV (i.e., CNV previously diagnosed and treated with anti-vascular endothelial growth factor (VEGF) therapy resulting in resolution of leakage or optical coherence tomography (OCT) thickening but currently presenting with new fluorescein leakage from CNV associated with OCT thickening) 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 (approximate Snellen equivalent, 20/40 to 20/320) at a starting distance of 4 meters.
  • No contraindication to intravitreal ranibizumab injection.
  • Postmenopausal for at least 12 months prior to enrollment or surgically sterile or practicing medically acceptable form of birth control and not pregnant (per serum pregnancy test) at time of enrollment. Male subjects must be practicing a medically acceptable form of birth control (e.g., abstinence or barrier method with spermicide).
  • Signed informed consent documenting an informed consent process.

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 surgery in the study eye.
    • History of glaucoma filtering surgery in the study eye.
    • History of corneal transplant in the study eye.
    • History of submacular surgery or other surgical intervention for AMD 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, Stakel® Solution, or fluorescein, affect interpretation of study results, 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, such as ocular histoplasmosis, trauma, or pathologic myopia.
    • Retinal pigment epithelial tear involving the macula in the study eye.
  • Concurrent Ocular Conditions

    • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator, could either require medical or surgical intervention during study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least two Snellen equivalent lines of BCVA over the study period.
    • Active intraocular inflammation (grade trace or above) in the study eye.
    • Current vitreous hemorrhage in the study eye.
    • History of 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. Previous opening of the posterior capsule in the study eye within 2 weeks of study treatment is also excluded unless it occurred because of Ytrium-Aluminum-Garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
    • Spherical equivalent of the refractive error in the study eye demonstrating more-than eight diopters of myopia. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 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 (defined as intraocular pressure (IOP) ≥30 mmHg despite treatment with anti-glaucoma medication)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021956

Locations
United States, Maryland
Johns Hopkins,Wilmer Eye Institute
Baltimore, Maryland, United States, 21205
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, Texas
Valley Retina Institute
Harlingen, Texas, United States, 78550
France
Hotel Dieu de Paris Hospital
Paris, France, 75004
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
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
  More Information

No publications provided

Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT01021956     History of Changes
Other Study ID Numbers: CLIN905 MLT202
Study First Received: November 29, 2009
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Steba Biotech S.A.:
Macular Degeneration
Age Related Macular Degeneration
Choroidal Neovascularization
AMD
CNV
WST11
Stakel
Photodynamic therapy
Vascular Targeted Photodynamic therapy
VTP

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on April 17, 2014