Macular DegenerationPhase 2NCT01021956
Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
A Phase 2 study testing STAKEL in people with Macular Degeneration and Choroidal Neovascularization, run by Steba Biotech S.A. at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- STAKEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2010to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Johns Hopkins,Wilmer Eye Institute
Baltimore, Maryland, 21287
Valley Retina Institute
Harlingen, Texas, 78550
Palmetto Retina Center
West Columbia, South Carolina, 29169
About this study
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)
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).
Read the 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).
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Being tested
- STAKEL
- Keywords
- Macular Degeneration, Age Related Macular Degeneration, Choroidal Neovascularization, AMD, CNV, WST11, Stakel, Photodynamic therapy, Vascular Targeted Photodynamic therapy, VTP
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAKELDrug
Also called WST11
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.
| Study group | Role | What they receive |
|---|---|---|
| WST11 (STAKEL) | Experimental | 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. Receives: Drug: STAKEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 week follow-up
Secondary outcomes (1)
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)
Measured: Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionJan 2014
Why it stopped: Retinal vascular occlusion in 2 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Bressler, Professor, Study chair, Johns Hopkins UniversityVictor Gonzalez, Professor, Principal investigator, Valley Retina InstituteJohn Wells, Professor, Principal investigator, Palmetto Retina CenterFrancine Behar Cohen, Professor, Principal investigator, Hotel Dieu HospitalAdrienne Scott, Doctor, Principal investigator, Johns Hopkins/ Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021956
- Sponsor's protocol ID
- CLIN905 MLT202
- Status last verified
- Sep 2018
- First submitted
- 29 Nov 2009
- Last updated
- 17 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The data are available in case report form for each patient
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01021956
- Acronym / sponsor ID
- CLIN905 MLT202
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Keywords
- Macular Degeneration, Age Related Macular Degeneration, Choroidal Neovascularization, AMD, CNV, WST11, Stakel, Photodynamic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Retinal vascular occlusion in 2 patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Posted 17 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WST11 (STAKEL) | Experimental | Drug: STAKELSingle 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- Prior treatments:
- Lesion Characteristics
- Concurrent Ocular Conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAKELAlso: WST11Open-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. | Drug | WST11 (STAKEL) |
Primary outcome
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.
1 secondary outcome
Visual Acuity
Time frame: Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The data are available in case report form for each patient
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Bressler, Professor study chair
Johns Hopkins University
Victor Gonzalez, Professor principal investigator
Valley Retina Institute
John Wells, Professor principal investigator
Palmetto Retina Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STAKEL in people with Macular Degeneration and Choroidal Neovascularization, run by Steba Biotech S.A. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) - Number of Subjects With Eye Disorders (time frame: 12 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.