Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
Condition: Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: STAKEL
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Macular Degeneration; Age Related Macular Degeneration; Choroidal Neovascularization; AMD; CNV; WST11; Stakel; Photodynamic therapy; Vascular Targeted Photodynamic therapy; VTP

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        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.