Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD
Public ClinicalTrials.gov record NCT01414153. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2a, Multicenter, Masked, Randomized, Comparator Controlled Study Evaluating iSONEP™ as Monotherapy or Adjunctive Therapy to Lucentis/Avastin/Eylea Versus Lucentis/Avastin/Eylea Alone for Treatment of Subjects With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01414153
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 158 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2012 (Type not available)
- Primary completion
- May 2015 (Actual)
- Completion
- Jun 2015 (Actual)
- Last update posted
- Oct 17, 2016
2012 – 2015
United States locations
- U.S. sites
- 44
- U.S. states
- 19
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retina Consultants of Arizona | Peoria | Arizona | 85381 | — |
| Retina Consultants of Arizona | Phoenix | Arizona | 85014 | — |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | — |
| Retina Centers, P.C. | Tucson | Arizona | 85704 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| Retinal Diagnostic Center | Campbell | California | 95008 | — |
| Specialty Eye Care Medical Center | Glendale | California | 91203 | — |
| Retina Associates of Orange County | Laguna Hills | California | 92653 | — |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | — |
| Sagar Kenyon American Eye Institute | New Albany | California | 47150 | — |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95819 | — |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | — |
| Miramar Eye Specialists | Ventura | California | 93003 | — |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | — |
| Retina Health Center | Fort Myers | Florida | 33907 | — |
| Retina Specialty Institute | Pensacola | Florida | 32503 | — |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | — |
| East Florida Eye Institute | Stuart | Florida | 34994 | — |
| Center for Retina & Macular Disease | Winter Haven | Florida | 33880 | — |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | — |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | — |
| Central Plains Eye MDs | Wichita | Kansas | 67226 | — |
| Bennett & Bloom Eye Centers | Louisville | Kentucky | 40207 | — |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | — |
| Retina Specialists | Towson | Maryland | 21204 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| TLC Eye Care and Laser Center | Jackson | Michigan | 49202 | — |
| Retina Consultants of Michigan | Southfield | Michigan | 48034 | — |
| Island Retina | Shirley | New York | 11967 | — |
| Charlotte Eye Ear Nose & Throat Associates | Charlotte | North Carolina | 28210 | — |
| Retina & Vitreous Center SO | Ashland | Oregon | 97520 | — |
| Associates in Ophthalmology | West Mifflin | Pennsylvania | 15122 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Retina Research Center | Austin | Texas | 78705 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| Valley Retina Institute | Harlingen | Texas | 78550 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Associates of South Texas | San Antonio | Texas | 78240 | — |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | — |
| Retina Group of Washington | Fairfax | Virginia | 22031 | — |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01414153, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 17, 2016 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01414153 live on ClinicalTrials.gov.