Pigment Epithelial DetachmentPhase 1PEDNCT01334255
iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
A Phase 1 study testing iSONEP (sonepcizumab/LT1009) in people with Pigment Epithelial Detachment, run by Lpath, Inc. at 5 sites in United States.
Trial summary
LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pigment Epithelial Detachment
- What is being tested?
- iSONEP (sonepcizumab/LT1009)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Males and females > 50 years of age with a diagnosis of PED secondary to AMD or PCV
- Serous and/or fibrovascular PED secondary to exudative AMD or secondary to PCV (confirmed by SDOCT, FA and ICG) that has not demonstrated at least a 25% decrease in the height of the PED (from the onset of anti-VEGF therapy) following a minimum of 3 doses of an anti-VEGF agent (i.e., Lucentis or Avastin)
- PED that has a height greater than 100 μm
- Presence of CNV secondary to (i) AMD (based on FA) or (ii) PCV (based on ICG)
- ETDRS BCVA of 20/32 to 20/320 (letter score of 73 to 25) in the study eye
- ETDRS visual acuity of 20/400 or better in the fellow eye
Who cannot join
- Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
- Subjects who have received < 3 and > 7 anti-VEGF treatments in the study eye
- Subjects with retinal angiomatous proliferation (RAP lesion)
- Lucentis or Avastin within 30 days prior to Day 1 in the study eye
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Retina Research Center
Austin, Texas, 78705
Palmetto Retina Center
West Columbia, South Carolina, 29169
Associates in Ophthalmology
West Mifflin, Pennsylvania, 15122
Center For Retina & Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Phase 1b Multi-Center, Open-Label and Randomized Study of iSONEP (Sonepcizumab/LT1009) Administered as Intravitreous Injections to Subjects With PED Secondary to Exudative Age-Related Macular Degeneration or Polypoidal Choroidal Vasculopathy
LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).
Read the detailed description
Sixteen (16) subjects per dose group who have received a minimum of 3 and no more than 7 doses of an anti-VEGF agent (i.e., Lucentis or Avastin), and whose PED has not decreased by greater than 25% in height despite therapy, will be enrolled for a total of 32 subjects. The presence of PED diagnosed by the Investigator will be confirmed by SDOCT, ICG and FA by a digital imaging reading center prior to subject enrollment. The ability of iSONEP to induce regression of persistent PED in subjects with exudative AMD or PCV despite previous treatment with an anti-VEGF agent will be evaluated.
- Conditions
- Pigment Epithelial Detachment
- Being tested
- iSONEP (sonepcizumab/LT1009)
- Keywords
- Pigment epithelial detachment, Exudative age-related macular degeneration, Polypoidal choroidal vasculopathy
- Medical subject headings
- Retinal Detachment, Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSONEP (sonepcizumab/LT1009)Drug
Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg of iSONEP (sonepcizumab/LT1009) | Experimental | iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate Receives: Drug: iSONEP (sonepcizumab/LT1009) |
| 2.0 mg of iSONEP (sonepcizumab/LT1009) | Experimental | iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate Receives: Drug: iSONEP (sonepcizumab/LT1009) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP
The number of participants with adverse events; changes in electrocardiogram parameters, diastolic and systolic blood pressure, pulse, temperature and intraocular pressure from baseline to the end of the study.
Measured: 8 months
Secondary outcomes (3)
To evaluate various efficacy outcomes throughout the study
- Changes in subretinal and intraretinal fluid, in retinal thickness and in size and height of PED compared with baseline at Days 30, 45, 60 and 90
- Changes in CNV lesion area from baseline
- Time course to regression of PED; proportion of subjects with complete resolution of PED following a single, second or third IVT iSONEP injection
- Changes in VA; proportion of eyes gaining > or = 0, 5, 10 and 15 letters on ETDRS
- Proportion of subjects with an improvement from baseline in VFQ-25 overall composite score to Day 60, Month 4 and Month 8
- Time to re-treatment with anti-VEGF therapy
Measured: 8 months
To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections
Production and/or changes in antibody concentration to iSONEP from baseline to the end of the study
Measured: 8 months
To characterize the systemic pharmacokinetic profile of iSONEP
For the 2.0 mg dose of iSONEP
- Maximum plasma concentration
- Area under the concentration versus time curve
- Terminal half-life
- Terminal elimination constant
- Time of maximum concentration
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionJul 2012
Why it stopped: Sponsor decision; not safety related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigment Epithelial DetachmentStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lpath, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Glenn Stoller, MD, Study chair, Lpath, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334255
- Sponsor's protocol ID
- LT1009-Oph-002
- Acronym
- PED
- Status last verified
- Jan 2012
- First submitted
- 8 Apr 2011
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multi-Center, Open-Label and Randomized Study of iSONEP (Sonepcizumab/LT1009) Administered as Intravitreous Injections to Subjects With PED Secondary to Exudative Age-Related Macular Degeneration or Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT01334255
- Acronym / sponsor ID
- PED / LT1009-Oph-002
- Conditions
- Pigment Epithelial Detachment
- Keywords
- Pigment epithelial detachment, Exudative age-related macular degeneration, Polypoidal choroidal vasculopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision; not safety related
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lpath, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).
Detailed description
Sixteen (16) subjects per dose group who have received a minimum of 3 and no more than 7 doses of an anti-VEGF agent (i.e., Lucentis or Avastin), and whose PED has not decreased by greater than 25% in height despite therapy, will be enrolled for a total of 32 subjects. The presence of PED diagnosed by the Investigator will be confirmed by SDOCT, ICG and FA by a digital imaging reading center prior to subject enrollment. The ability of iSONEP to induce regression of persistent PED in subjects with exudative AMD or PCV despite previous treatment with an anti-VEGF agent will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg of iSONEP (sonepcizumab/LT1009) | Experimental | Drug: iSONEP (sonepcizumab/LT1009)iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate |
| 2.0 mg of iSONEP (sonepcizumab/LT1009) | Experimental | Drug: iSONEP (sonepcizumab/LT1009)iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females > 50 years of age with a diagnosis of PED secondary to AMD or PCV
- Serous and/or fibrovascular PED secondary to exudative AMD or secondary to PCV (confirmed by SDOCT, FA and ICG) that has not demonstrated at least a 25% decrease in the height of the PED (from the onset of anti-VEGF therapy) following a minimum of 3 doses of an anti-VEGF agent (i.e., Lucentis or Avastin)
- PED that has a height greater than 100 μm
- Presence of CNV secondary to (i) AMD (based on FA) or (ii) PCV (based on ICG)
- ETDRS BCVA of 20/32 to 20/320 (letter score of 73 to 25) in the study eye
Key exclusion criteria (4 listed)
- Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
- Subjects who have received < 3 and > 7 anti-VEGF treatments in the study eye
- Subjects with retinal angiomatous proliferation (RAP lesion)
- Lucentis or Avastin within 30 days prior to Day 1 in the study eye
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 |
|---|---|---|
| iSONEP (sonepcizumab/LT1009)Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office. | Drug | 0.5 mg of iSONEP (sonepcizumab/LT1009), 2.0 mg of iSONEP (sonepcizumab/LT1009) |
Primary outcome
To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP
Time frame: 8 months
The number of participants with adverse events; changes in electrocardiogram parameters, diastolic and systolic blood pressure, pulse, temperature and intraocular pressure from baseline to the end of the study.
3 secondary outcomes
To evaluate various efficacy outcomes throughout the study
Time frame: 8 months
To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections
Time frame: 8 months
To characterize the systemic pharmacokinetic profile of iSONEP
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Sponsor decision; not safety related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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.
Glenn Stoller, MD study chair
Lpath, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iSONEP (sonepcizumab/LT1009) in people with Pigment Epithelial Detachment, run by Lpath, Inc. at 5 sites in United States.
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 6 inclusion and 4 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 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision; not safety related). Results are not available in the source record.
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?
To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP (time frame: 8 months). 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 23 Apr 2013.