A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®)-Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects with Choroidal Neovasularization (CNV) Associated with Age-Related Macular Degeneration (AMD)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-017435-18-FR
• Date of registration: 10/12/2009
• Prospective Registration: Yes
• Primary sponsor: Steba Biotech S.A.
• Public title: A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®)-Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects with Choroidal Neovasularization (CNV) Associated with Age-Related Macular Degeneration (AMD)
• Scientific title: A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®)-Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects with Choroidal Neovasularization (CNV) Associated with Age-Related Macular Degeneration (AMD)
• Date of first enrolment: 04/02/2010
• Target sample size: 18
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017435-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
• Men and women, 50 years of age or older.
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Prior treatments:
o Previous subfoveal laser photocoagulation, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye at any time.
o Using anti-VEGF therapies for other indications (e.g., cancer) in the 30 days prior to the study and/or during the study
o Received intravitreal injection of ranibizumab or bevacizumab in either eye during less than 28 days prior to Day 1 of the study.
o More than three previous photodynamic therapy (PDT) treatments in the preceding 12 months.
o Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within the preceding month.
o History of vitrectomy surgery in the study eye.
o History of glaucoma filtering surgery in the study eye.
o History of corneal transplant in the study eye.
o History of submacular surgery or other surgical intervention for AMD in the study eye.
o Previous participation in any studies of investigational drugs within 1 month preceding Day 1 (excluding vitamins and minerals).

• Lesion Characteristics
o 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.
o 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.
o Subfoveal fibrosis or atrophy in the study eye which is at least 50% of the lesion.
o CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
o Retinal pigment epithelial tear involving the macula in the study eye.

• Concurrent Ocular Conditions
o 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.
o Active intraocular inflammation (grade trace or above) in the study eye.
o Current vitreous hemorrhage in the study eye.
o History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
o History of idiopathic or autoimmune-associated uveitis in either eye.
o Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
o Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless it occurred because of Ytrium-Aluminum-Garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
o 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.
o Intraocular surgery (including cataract surgery) in the study eye within three months preceding Day 1.
o Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) =30 mmHg despite treatment with anti-glaucoma medication)

• Other
o Porphyria or other porphyri

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Age associated Macular Degeneration
MedDRA version: 12.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration
MedDRA version: 12.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration

Intervention(s)

Product Name: Stakel
Product Code: WST11
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Padeliporfin
CAS Number: 886845-72-3
Current Sponsor code: WST11
Other descriptive name: Palladium Bacteriopheophorbide Monolysotaurine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To evaluate the safety and efficacy of treatment with WST11 (Stakel®) and Vascular-Targeted Photodynamic (VTP) therapy.

Secondary Objective: To explore the effect of treatment with WST11 (Stakel®) and Vascular-Targeted Photodynamic (VTP) therapy in subjects with neovascular AMD.

The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti-VEGF intraviteral therapy for the first 12 weeks after VTP.

Primary end point(s): The primary objective of this Phase IIa clinical study is to evaluate the safety of treatment with Stakel® in subjects with neovascular AMD.

Secondary ID(s)

CLIN905 MLT202