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Monoclonal Antibodies

1 for Age-Related Macular Degeneration

Phase 1
Waitlist Available
Research Sponsored by Lpath, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up active phase: 30 days post-injection; follow-up phase: 12 months post-injection
Awards & highlights

Study Summary

Age-related macular degeneration (AMD) is a disease that, in time, destroys the macula, which is the central part of the retina that gives sharp central vision. The primary purpose of this study is to assess the safety of iSONEP which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P).

Eligible Conditions
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~active phase: 30 days post-injection; follow-up phase: 12 months post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and active phase: 30 days post-injection; follow-up phase: 12 months post-injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine safety, tolerability, maximum tolerated dose and dose-limiting toxicity of iSONEP following a single intravitreal injection to subjects with choroidal neovascularization secondary to AMD
Secondary outcome measures
To characterize systemic pharmacokinetics, evaluate the immunogenicity, and investigate preliminary efficacy on retinal lesion thickness determined by OCT; size and extent of CNV and lesion area; and visual acuity

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
iSONEP

Find a Location

Who is running the clinical trial?

Lpath, Inc.Lead Sponsor
5 Previous Clinical Trials
283 Total Patients Enrolled
Glenn Stoller, MDStudy DirectorLpath, Inc.
2 Previous Clinical Trials
152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration
2008. "Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00767949.
All > Age Related Macular Degeneration > Macular Degeneration
~1 spots leftby Apr 2025
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