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NCT01414153 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD
A Phase 2 study of Exudative Age-Related Macular Degeneration, sponsored by Lpath.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
- 20
- Study locations
NCT01414153: Completed Phase 2 study of Exudative Age-Related Macular Degeneration, sponsored by Lpath.
NCT01414153 is a Phase 2 study of Exudative Age-Related Macular Degeneration that has completed, run by Lpath. The registered enrollment target is 158 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01414153, a Phase 2 study of Exudative Age-Related Macular Degeneration, has completed, sponsored by Lpath.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet Age-related Macular Degeneration (AMD). iSONEP not only has an anti-permeability effect, but also has anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. The drug may therefore have the ability to achieve better visual outcomes than Lucentis, Avastin or Eylea, particularly in those subjects who do not demonstrate a robust response to Lucentis, Avastin or Eylea after several monthly injections. Further, the combination of Lucentis, Avastin or Eylea and iSONEP may be additive or synergistic. By inhibiting the multiple mechanisms that contribute to exudative-AMD-related vision loss, better visual outcomes may be possible than with Lucentis, Avastin or Eylea alone.
Primary Outcome
Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.
Conditions Studied
Interventions
- DRUG 4.0 mg iSONEP
- DRUG 0.5 mg iSONEP
- DRUG 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea
- DRUG sham injection
Study Locations (20)
California
- Retina-Vitreous Associates Medical Group - Beverly Hills
- Retinal Diagnostic Center - Campbell
- Specialty Eye Care Medical Center - Glendale
- Retina Associates of Orange County - Laguna Hills
- Northern California Retina Vitreous Associates - Mountain View
- Sagar Kenyon American Eye Institute - New Albany
- Retinal Consultants Medical Group, Inc. - Sacramento
- Orange County Retina Medical Group - Santa Ana
- Miramar Eye Specialists - Ventura
Florida
- Florida Eye Microsurgical Institute - Boynton Beach
- Retina Health Center - Fort Myers
- Retina Specialty Institute - Pensacola
- Fort Lauderdale Eye Institute - Plantation
- East Florida Eye Institute - Stuart
- Center for Retina & Macular Disease - Winter Haven
Arizona
- Retina Consultants of Arizona - Peoria
- Retina Consultants of Arizona - Phoenix
- Associated Retina Consultants - Phoenix
- Retina Centers, P.C. - Tucson
Hawaii
- Retina Consultants of Hawaii - ‘Aiea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01414153 record still lists
NCT01414153 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Exudative Age-Related Macular Degeneration appearing as the primary indexed condition, and to 4 interventions - of which 4.0 mg iSONEP is the first listed.
NCT01414153 names 20 study sites across 4 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01414153 about?
NCT01414153 is a clinical study titled "Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD". The purpose of the study is to determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet Age-related Macular Degeneration (AMD). iSONEP not only has an anti-permeability effect, but also has anti-angiogenic,...
What is the current status of trial NCT01414153?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2012-08. Estimated completion is 2015-06.
What conditions does trial NCT01414153 study?
This clinical trial studies the following conditions: Exudative Age-Related Macular Degeneration.
What interventions are being tested in trial NCT01414153?
The interventions under investigation include: 4.0 mg iSONEP (DRUG), 0.5 mg iSONEP (DRUG), 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea (DRUG), sham injection (DRUG).
Who is sponsoring clinical trial NCT01414153?
This trial is sponsored by Lpath, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01414153 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01414153's enrollment target sits among peer trials
158 443rd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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