Clinical trial NCT01021956: Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Steba Biotech S.A.
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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 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.

Primary outcomes:
measure: Adverse Events (AEs) - Number of Subjects With Eye Disorders
timeFrame: 12 week follow-up
Secondary outcomes:
measure: Visual Acuity
timeFrame: Week 12.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins,Wilmer Eye Institute
state: Maryland
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Harlingen
country: United States
facility: Valley Retina Institute
state: Texas
city: Paris
country: France
facility: Hotel Dieu de Paris Hospital
Study officials:
affiliation: Johns Hopkins University
name: Neil Bressler, Professor
role: STUDY_CHAIR
affiliation: Valley Retina Institute
name: Victor Gonzalez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Retina Center
name: John Wells, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Hospital
name: Francine Behar Cohen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins/ Wilmer Eye Institute
name: Adrienne Scott, Doctor
role: PRINCIPAL_INVESTIGATOR
References: