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

• 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.

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.

• Macular Degeneration
• Choroidal Neovascularization

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)