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Choroidal NeovascularizationPhase 2EMERGENCT02358889

Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

A Phase 2 study testing hI-con1 and ranibizumab in people with Choroidal Neovascularization and Age-related Macular Degeneration, run by Iconic Therapeutics, Inc. at 48 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
hI-con1 and ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
48 sitesUnited States
Study dates
Feb 2015to Sep 2016
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

  • Males or females of any race at least 50 years of age
  • Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye
  • Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye

Who cannot join

  • Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye
  • Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
  • Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
  • Vitrectomy in the study eye
  • Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Arcadia, California, 91007

  • Study site

    Ashland, Oregon, 97520

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Bloomfield, New Jersey, 07003

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Brooklyn, New York, 11223

  • Study site

    Campbell, California, 95008

  • Study site

    Detroit, Michigan, 48072

  • Study site

    Fort Myers, Florida, 33907

  • Study site

    Glendale, California, 91203

  • Study site

    Golden, Colorado, 80401

  • Study site

    Hauppauge, New York, 11788

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntingdon Valley, Pennsylvania, 19006

  • Study site

    Jackson, Michigan, 49202

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Las Vegas, Nevada, 89144

  • Study site

    Madison, Wisconsin, 53705

  • Study site

    McAllen, Texas, 78503

  • Study site

    Minneapolis, Minnesota, 55435

  • Study site

    Mountain View, California, 94040

  • Study site

    Paducah, Kentucky, 42001

  • Study site

    Palm Desert, California, 92260

  • Study site

    Palo Alto, California, 94303

  • Study site

    Panama City, Florida, 32405

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85020

  • Study site

    Phoenix, Arizona, 85021

  • Study site

    Portland, Oregon, 97210

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78240

  • Study site

    San Francisco, California, 94109

  • Study site

    Santa Ana, California, 92705

  • Study site

    Sarasota, Florida, 34233

  • Study site

    Silverdale, Washington, 98383

  • Study site

    Stuart, Florida, 34994

  • Study site

    Syracuse, New York, 13224

  • Study site

    The Woodlands, Texas, 77384

  • Study site

    West Bloomfield, Michigan, 48322

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    Winter Haven, Florida, 33907

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Being tested
hI-con1, ranibizumab, Sham injection
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.

  • hI-con1Biological

    Also called human Immuno-conjugate 1

    Intravitreal injection of hI-con1 0.3 mg

  • ranibizumabBiological

    Also called Lucentis®

    Intravitreal injection of ranibizumab 0.5 mg

  • Sham injectionOther

    No injection is given, a needleless syringe is used to mimic an injection.

Study groups in NCT02358889
Study groupRoleWhat they receive
hI-con1ExperimentalPatients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Receives: Biological: hI-con1; Other: Sham injection
hI-con1 + ranibizumabExperimentalPatients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Receives: Biological: hI-con1; Biological: ranibizumab
ranibizumabActive comparatorPatients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Receives: Biological: ranibizumab; Other: Sham injection

What is being measured

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

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3

    Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.

    Measured: Baseline and Month 3

  2. Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3

    Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.

    Measured: Baseline and Month 3

Secondary outcomes (2)

  1. Change From Baseline in BCVA in the Study Eye at Month 6

    Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.

    Measured: Baseline and Month 6

  2. Change From Baseline in CST in the Study Eye at Month 6

    Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement.

    Measured: Baseline and Month 6

Timeline

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

  1. First posted9 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

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, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02358889
Sponsor's protocol ID
IT-002
Acronym
EMERGE
Status last verified
Sep 2020
First submitted
4 Feb 2015
Last updated
24 Sep 2020

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hI-con1 and ranibizumab in people with Choroidal Neovascularization and Age-related Macular Degeneration, run by Iconic Therapeutics, Inc. at 48 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 3 inclusion and 5 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 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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 24 Sep 2020). 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?

Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 (time frame: Baseline and Month 3). The study lists 2 primary outcomes in all. 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 NCT02358889.

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 24 Sep 2020.

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