AzTrials
AzTrials

Exudative Age-related Macular DegenerationPhase 2NexusNCT01414153

Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD

A Phase 2 study testing 4.0 mg iSONEP, 0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea in people with Exudative Age-related Macular Degeneration, run by Lpath, Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
4.0 mg iSONEP, 0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
44 sitesUnited States
Study dates
Aug 2012to Jun 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • ≥50 years of age with a diagnosis of wet AMD
  • Subjects who have received 3 injections of Lucentis or Avastin or Eylea within 12 months prior to screening
  • Active subfoveal CNV secondary to AMD (leakage on FA)
  • Presence of residual subretinal or intraretinal fluid on Cirrus or Spectralis SDOCT
  • SDOCT in the 1 mm central macular subfield on the retinal map analysis of ≥250 μm at screening
  • ETDRS BCVA of ≥25 and ≤73 letters (approximately 20/320 and 20/40 on the Snellen scale) at screening and on Day 0
  • In the fellow eye, ETDRS BCVA of 20/400 or better
  • Subject with serous pigment epithelial detachment (PED) (any part of which may be subfoveal) with intraretinal and/or subretinal fluid may be included

Who cannot join

  • Most recent IVT injection of Lucentis or Avastin fewer than 28 days and more than 65 days prior to screening
  • Most recent IVT injection of Eylea fewer than 42 days and more than 79 days prior to screening
  • Previous photodynamic therapy (PDT) or Macugen® at any time point
  • Focal thermal laser or grid laser within 3 months prior to Day 0
  • Use of IVT, subtenon or subconjunctival steroids within 3 months prior to Day 0
  • Use of topical ophthalmic corticosteroids 2 weeks prior to Day 0
Show all 20Show fewer
  • Intraocular surgery, including cataract surgery, and / or laser of any type within 3 months prior to Day 0 or anticipated need for ocular surgery or ophthalmic laser treatment during the study period
  • Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
  • Retinal total lesion size >12 disc areas (30.5 mm2), including blood, scars and neovascularization as assessed by FA in the study eye
  • Presence of a fibrovascular PED extending underneath the center of the fovea
  • Presence of retinal angiomatous proliferation (RAP) lesions
  • Presence of polypoidal choroidal vasculopathy (PCV) (if suspected, Indocyanine Green Angiography (ICG) should be performed at the discretion of the Investigator)
  • Subretinal hemorrhage in the study eye if any of the following is true: (i) the subretinal hemorrhage represents 50% or more of the total lesion area; (ii) subfoveal blood is 1 or more disc areas in size (iii) subfoveal blood where the fovea is surrounded by less than 270 degrees of visible CNV on FA
  • Scar or fibrosis making up >50% of total lesion area in the study eye
  • Anatomic damage to the center of the fovea including fibrosis, scarring or atrophy
  • History of a retinal pigment epithelial tear
  • History of vitreous hemorrhage within 4 weeks prior to screening in the study eye
  • Clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye
  • Uncontrolled glaucoma defined as: (i) as intraocular pressure ≥25 mmHg despite treatment with anti glaucoma medication in the study eye or (ii) by the Investigator
  • Prior trabeculectomy or other filtration surgery in the study eye (prior laser trabeculoplasty is allowed)

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Retina & Vitreous Center SO

    Ashland, Oregon, 97520

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Florida Eye Microsurgical Institute

    Boynton Beach, Florida, 33426

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Charlotte Eye Ear Nose & Throat Associates

    Charlotte, North Carolina, 28210

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Retina Group of Washington

    Fairfax, Virginia, 22031

  • Retina Health Center

    Fort Myers, Florida, 33907

  • Specialty Eye Care Medical Center

    Glendale, California, 91203

  • Valley Retina Institute

    Harlingen, Texas, 78550

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • TLC Eye Care and Laser Center

    Jackson, Michigan, 49202

  • Retina Associates of Orange County

    Laguna Hills, California, 92653

  • Bennett & Bloom Eye Centers

    Louisville, Kentucky, 40207

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Sagar Kenyon American Eye Institute

    New Albany, California, 47150

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Retina Consultants of Arizona

    Peoria, Arizona, 85381

  • Retina Consultants of Arizona

    Phoenix, Arizona, 85014

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95819

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Associates of South Texas

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • Island Retina

    Shirley, New York, 11967

  • Retina Consultants of Michigan

    Southfield, Michigan, 48034

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Retina Specialists

    Towson, Maryland, 21204

  • Retina Centers, P.C.

    Tucson, Arizona, 85704

  • Miramar Eye Specialists

    Ventura, California, 93003

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Associates in Ophthalmology

    West Mifflin, Pennsylvania, 15122

  • Central Plains Eye MDs

    Wichita, Kansas, 67226

  • Center for Retina & Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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)

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.

Read the detailed description

The study will be conducted in subjects who qualify as "sub-responders" to Lucentis, Avastin or Eylea meaning that each subject has (i) residual subretinal or intra-retinal fluid observed on Cirrus or Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT), (ii) leakage on fluorescein angiogram (FA), and (iii) an average central subfield thickness of ≥250 μm. Additionally, each subject will have previously received a minimum of 3 intravitreous (IVT) injections of Lucentis, Avastin or Eylea within the 12-month period prior to screening. Screening must occur between 28 and 65 days from the subject's last Lucentis or Avastin treatment or between 42 and 79 days from the subject's last Eylea treatment. Subjects must be dosed within 14 days of screening, and as of the day of initial study treatment (Day 0), meet the following criteria: (i) Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected visual acuity (BCVA) of ≥25 and ≤73 letters (approximately 20/320 and 20/40 on the Snellen scale), (ii) residual subretinal or intra-retinal fluid observed on Cirrus or Spectralis SDOCT, and (iii) leakage on FA.

Being tested
4.0 mg iSONEP, 0.5 mg iSONEP, 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea, sham injection
Keywords
choroidal neovascularization, age-related macular degeneration, iSONEP, sonepcizumab, Lucentis, ranibizumab, Avastin, bevacizumab, Eylea, aflibercept
Medical subject headings
Choroidal Neovascularization, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4.0 mg iSONEPDrug

    Also called sonepcizumab

    4.0 mg iSONEP given monthly intravitreously for 4 months

  • 0.5 mg iSONEPDrug

    Also called sonepcizumab

    0.5 mg iSONEP given monthly intravitreously for 4 months

  • 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg EyleaDrug

    Also called ranibizumab, bevacizumab, aflibercept

    0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea given monthly intravitreously for 4 months

  • sham injectionDrug

    Also called placebo

    administered monthly for 4 months

Study groups in NCT01414153
Study groupRoleWhat they receive
MonotherapyExperimental4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
Receives: Drug: 4.0 mg iSONEP; Drug: sham injection
0.5 mg iSONEP & Lucentis/Avastin/EyleaExperimental0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
Receives: Drug: 0.5 mg iSONEP; Drug: 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea
4.0 mg iSONEP & Lucentis/Avastin/EyleaExperimental4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
Receives: Drug: 4.0 mg iSONEP; Drug: 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea
Lucentis or Avastin or EyleaActive comparator0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
Receives: Drug: 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; Drug: sham injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)

    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.

    Measured: Baseline to Day 120

Secondary outcomes (6)

  1. Mean Change in Central Subfield Retinal Thickness

    Measured: Baseline to Day 120

  2. Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).

    Measured: Baseline to Day 120

  3. Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.

    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.

    Measured: Baseline to Day 120

  4. Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.

    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. One line is equivalent to 5 letters, so a loss of 3 lines is a loss of 15 letters.

    Measured: Baseline to Day 120

  5. Proportion of Subjects With ETDRS BCVA of 20/40 or Better.

    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. 20/40 Snellen corresponds to a range of 69-73 letters by ETDRS.

    Measured: Baseline to Day 120

  6. Proportion of Subjects With Adverse Events.

    Measured: Baseline to Day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2011 (estimated)
  2. Study startAug 2012
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01414153
Sponsor's protocol ID
LT1009-Oph-003
Acronym
Nexus
Status last verified
Aug 2016
First submitted
9 Aug 2011
Last updated
17 Oct 2016
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4.0 mg iSONEP, 0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea in people with Exudative Age-related Macular Degeneration, run by Lpath, Inc. at 44 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) (time frame: Baseline to Day 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01414153.

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 17 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in