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

Primary Purpose

Macular Degeneration, Choroidal Neovascularization

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

STAKEL

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Macular Degeneration, Age Related Macular Degeneration, Choroidal Neovascularization, AMD, CNV, WST11, Stakel, Photodynamic therapy, Vascular Targeted Photodynamic therapy, VTP

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins,Wilmer Eye Institute
Palmetto Retina Center
Valley Retina Institute
Hotel Dieu de Paris Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WST11 (STAKEL)

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse Events (AEs) - Number of Subjects With Eye Disorders

Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.

Secondary Outcome Measures

Visual Acuity

Variation from baseline to week 12 in visual acuity score using Early Treatment Diabetic Retinopathy Study (ETDRS) 4.0 meter distance acuity chart. The patient is asked to read letter on a board from a distance of 4 meters. The charts use a geometric progression in letter size from line to line. The scores range from 0 (worse outcome) to 100/100 (best outcome)

Full Information

NCT ID

NCT01021956

First Posted

November 29, 2009

Last Updated

September 13, 2018

Sponsor

Steba Biotech S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01021956

Brief Title

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

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

Retinal vascular occlusion in 2 patients

Study Start Date

June 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Steba Biotech S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration, Choroidal Neovascularization

Keywords

Macular Degeneration, Age Related Macular Degeneration, Choroidal Neovascularization, AMD, CNV, WST11, Stakel, Photodynamic therapy, Vascular Targeted Photodynamic therapy, VTP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WST11 (STAKEL)

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

STAKEL

Other Intervention Name(s)

WST11

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.

Primary Outcome Measure Information:

Title

Adverse Events (AEs) - Number of Subjects With Eye Disorders

Description

Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.

Time Frame

12 week follow-up

Secondary Outcome Measure Information:

Title

Visual Acuity

Description

Time Frame

Week 12.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: