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Age-related Macular DegenerationPhase 3MAKONCT02727881

Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

A Phase 3 study testing Squalamine lactate ophthalmic solution, 0.2% and ranibizumab in people with Age-related Macular Degeneration, run by Ohr Pharmaceutical Inc. at 118 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. Read more about this study

Who is it for?
Ages 50 to 110 years
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
Squalamine lactate ophthalmic solution, 0.2% and ranibizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
118 sitesUnited States
Study dates
12 Apr 2016to Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

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 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 50 years
  • A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA)
  • Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
  • Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart)

Who cannot join

  • Neovascularization secondary to any other condition than AMD in the study eye; Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea
  • Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes
  • Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
  • Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
  • Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye

Trial locations and contacts

118 sites in 1 country.

118 sites in 1 country

United States118 sites

  • Investigational Site

    ‘Aiea, Hawaii, 96701

  • Investigational Site

    Altamonte Springs, Florida, 32701

  • Investigational Site

    Arcadia, California, 91007

  • Investigational Site

    Ashland, Oregon, 97520

  • Investigational Site

    Augusta, Georgia, 30909

  • Investigational Site

    Baltimore, Maryland, 21209

  • Investigational Site

    Baltimore, Maryland, 21237

  • Investigational Site

    Bellevue, Washington, 98004

  • Investigational Site

    Berwyn, Illinois, 60402

  • Investigational Site

    Beverly Hills, California, 90211

  • Investigational Site

    Biloxi, Mississippi, 39532

  • Investigational Site

    Bloomfield, New Jersey, 07003

  • Investigational Site

    Bloomington, Illinois, 61704

  • Investigational Site

    Boynton Beach, Florida, 33426

  • Investigational Site

    Bridgeport, Connecticut, 06606

  • Investigational Site

    Brooklyn, New York, 11223

  • Investigational Site

    Burlington, Vermont, 05401

  • Investigational Site

    Camp Hill, Pennsylvania, 17011

  • Investigational Site

    Campbell, California, 95008

  • Investigational Site

    Charlotte, North Carolina, 28210

  • Investigational Site

    Chesterfield, Missouri, 63017

  • Investigational Site

    Chicago, Illinois, 60612

  • Investigational Site

    Cleveland, Ohio, 44122

  • Investigational Site

    Cleveland, Ohio, 44130

  • Investigational Site

    Cleveland, Ohio, 44195

  • Investigational Site

    Columbia, South Carolina, 29223

  • Investigational Site

    Concord, North Carolina, 28025

  • Investigational Site

    Detroit, Michigan, 48201

  • Investigational Site

    Fairfax, Virginia, 22031

  • Investigational Site

    Florissant, Missouri, 63031

  • Investigational Site

    Fort Myers, Florida, 33901

  • Investigational Site

    Fort Worth, Texas, 76107

  • Investigational Site

    Fullerton, California, 92835

  • Investigational Site

    Glen Burnie, Maryland, 21061

  • Investigational Site

    Glendale, California, 91203

  • Investigational Site

    Glendora, California, 91741

  • Investigational Site

    Grand Rapids, Michigan, 49546

  • Investigational Site

    Grapevine, Texas, 76051

  • Investigational Site

    Great Neck, New York, 11021

  • Investigational Site

    Greenville, South Carolina, 29605

  • Investigational Site

    Hagerstown, Maryland, 21740

  • Investigational Site

    Hamden, Connecticut, 06518

  • Investigational Site

    Harlingen, Texas, 78550

  • Investigational Site

    Hauppauge, New York, 11788

  • Investigational Site

    Henderson, Nevada, 89052

  • Investigational Site

    Houston, Texas, 77030

  • Investigational Site

    Jackson, Michigan, 49202

  • Investigational Site

    Katy, Texas, 77494

  • Investigational Site

    Kingsport, Tennessee, 37660

  • Investigational Site

    Kingston, Pennsylvania, 18704

  • Investigational Site

    Kingwood, Texas, 77339

  • Investigational Site

    La Jolla, California, 92093

  • Investigational Site

    Laguna Hills, California, 92653

  • Investigational Site

    Lancaster, Pennsylvania, 17601

  • Investigational Site

    Las Vegas, Nevada, 89144

  • Investigational Site

    Lawrenceville, New Jersey, 08648

  • Investigational Site

    Leawood, Kansas, 66211

  • Investigational Site

    Loma Linda, California, 92354

  • Investigational Site

    Los Angeles, California, 90017

  • Investigational Site

    Louisville, Kentucky, 40202

  • Investigational Site

    Lynbrook, New York, 11563

  • Investigational Site

    Madison, Wisconsin, 53705

  • Investigational Site

    McAllen, Texas, 78503

  • Investigational Site

    Miami, Florida, 33136

  • Investigational Site

    Miami, Florida, 33143

  • Investigational Site

    Mobile, Alabama, 36608

  • Investigational Site

    Morgantown, West Virginia, 26501

  • Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • Investigational Site

    Naples, Florida, 34103

  • Investigational Site

    Nashville, Tennessee, 37203

  • Investigational Site

    New Albany, Indiana, 47150

  • Investigational Site

    New Brunswick, New Jersey, 08901

  • Investigational Site

    New London, Connecticut, 06320

  • Investigational Site

    New York, New York, 10003

  • Investigational Site

    New York, New York, 10032

  • Investigational Site

    Northfield, New Jersey, 08225

  • Investigational Site

    Oceanside, California, 92056

  • Investigational Site

    Orange, California, 92868

  • Investigational Site

    Paducah, Kentucky, 42001

  • Investigational Site

    Palm Desert, California, 92260

  • Investigational Site

    Palo Alto, California, 94303

  • Investigational Site

    Pasadena, California, 91107

  • Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Investigational Site

    Philadelphia, Pennsylvania, 19116

  • Investigational Site

    Phoenix, Arizona, 85014

  • Investigational Site

    Phoenix, Arizona, 85020

  • Investigational Site

    Phoenix, Arizona, 85021

  • Investigational Site

    Pikesville, Maryland, 21208

  • Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Investigational Site

    Plano, Texas, 75075

  • Investigational Site

    Portland, Maine, 04102

  • Investigational Site

    Portsmouth, New Hampshire, 03801

  • Investigational Site

    Poway, California, 92064

  • Investigational Site

    Ramsey, New Jersey, 07446

  • Investigational Site

    Rapid City, South Dakota, 57701

  • Investigational Site

    Redlands, California, 92374

  • Investigational Site

    Rochester, New York, 14620

  • Investigational Site

    Rockville, Maryland, 20877

  • Investigational Site

    Rockville Centre, New York, 11570

  • Investigational Site

    Royal Oak, Michigan, 48073

  • Investigational Site

    Sacramento, California, 91007

  • Investigational Site

    Salt Lake City, Utah, 84107

  • Investigational Site

    San Antonio, Texas, 78240

  • Investigational Site

    Sarasota, Florida, 34233

  • Investigational Site

    Southfield, Michigan, 48304

  • Investigational Site

    Spokane, Washington, 99204

  • Investigational Site

    Stuart, Florida, 34994

  • Investigational Site

    Sycamore, Illinois, 60178

  • Investigational Site

    Syracuse, New York, 13224

  • Investigational Site

    Teaneck, New Jersey, 07666

  • Investigational Site

    The Woodlands, Texas, 77384

  • Investigational Site

    Toledo, Ohio, 43615

  • Investigational Site

    Toms River, New Jersey, 07083

  • Investigational Site

    Traverse City, Michigan, 49686

  • Investigational Site

    Tucson, Arizona, 85704

  • Investigational Site

    Warrenton, Virginia, 20186

  • Investigational Site

    Youngstown, Ohio, 44505

Other trials in United States

About this study

Official title: OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint

Read the detailed description

Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months

(Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio:

  • Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks
  • Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks
Being tested
Squalamine lactate ophthalmic solution, 0.2%, Placebo Ophthalmic solution, ranibizumab
Keywords
AMD, CNV, choroidal neovascularization, retinal eye disease
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

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

  • Squalamine lactate ophthalmic solution, 0.2%Drug

    Also called active

    Squalamine lactate ophthalmic solution, 0.2%

  • Placebo Ophthalmic solutionDrug

    Also called placebo

    Placebo Ophthalmic solution

  • ranibizumabDrug

    Also called Lucentis

    ranibizumab

Study groups in NCT02727881
Study groupRoleWhat they receive
Squalamine solution, 0.2% BIDExperimentalSqualamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
Receives: Drug: Squalamine lactate ophthalmic solution, 0.2%; Drug: ranibizumab
Placebo solution BIDPlacebo comparatorPlacebo ophthalmic solution BID + ranibizumab every 4 weeks
Receives: Drug: Placebo Ophthalmic solution; Drug: ranibizumab

What is being measured

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

  1. Functional change in visual acuity

    Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration

    Measured: 9 months

Secondary outcomes (1)

  1. Functional changes in visual acuity

    Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration

    Measured: 9 months

Timeline

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

  1. First posted5 Apr 2016 (estimated)
  2. Study start12 Apr 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02727881
Sponsor's protocol ID
OHR-1601
Acronym
MAKO
Status last verified
Apr 2017
First submitted
28 Mar 2016
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Squalamine lactate ophthalmic solution, 0.2% and ranibizumab in people with Age-related Macular Degeneration, run by Ohr Pharmaceutical Inc. at 118 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Functional change in visual acuity (time frame: 9 months). 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 NCT02727881.

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 27 Apr 2017.

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