iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
NCT01334255
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV) | |||
| Official Title ICMJE | 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 | |||
| Brief 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 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Pigment Epithelial Detachment | |||
| Intervention ICMJE | Drug: iSONEP (sonepcizumab/LT1009)
Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office. | |||
| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 12 | |||
| Original Estimated Enrollment ICMJE | 32 | |||
| Actual Study Completion Date ICMJE | July 2012 | |||
| Actual Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01334255 | |||
| Other Study ID Numbers ICMJE | LT1009-Oph-002 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Lpath, Inc. | |||
| Study Sponsor ICMJE | Lpath, Inc. | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
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| PRS Account | Lpath, Inc. | |||
| Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||