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)
Overview
- Phase
- Phase 2
- Intervention
- STAKEL
- Conditions
- Macular Degeneration
- Sponsor
- Steba Biotech S.A.
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Adverse Events (AEs) - Number of Subjects With Eye Disorders
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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).
Investigators
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
Arms & Interventions
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: STAKEL
Outcomes
Primary Outcomes
Adverse Events (AEs) - Number of Subjects With Eye Disorders
Time Frame: 12 week follow-up
Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.
Secondary Outcomes
- Visual Acuity(Week 12.)