A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536016
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 21, 2010
Information provided by:
Jerini Ophthalmic

Brief Summary:
The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: JSM6427 Phase 1

Detailed Description:
In non-clinical models, JSM6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis. JSM6427 may also interfere with other key processes in the pathogenesis of AMD, namely inflammation and fibrosis. Further, non-clinical data show that JSM6427 inhibits scarring and inflammation. Thus, JSM6427 may target multiple important pathways in the pathogenesis of neovascular AMD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeated Doses of JSM6427 Following Administration by Intravitreal Injection in Patients With Neovascular AMD
Study Start Date : September 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: JSM6427
    Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml.

Primary Outcome Measures :
  1. Safety and Tolerability to determine the MTD [ Time Frame: 2 weeks after each dose ]

Secondary Outcome Measures :
  1. To evaluate the systemic pharmacokinetics of JSM6427 following single and repeat doses by intravitreal injection and to assess exploratory efficacy potential of JSM6427 [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Best corrected visual acuity in the study eye between 5 and 7 letters inclusive using and ETDRS chart (Snellen equivalent of appx. 20/800 to 20/40.
  • Subfoveal choroidal neovascularization (CNV) due to AMD.
  • Total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≤ 12 DA, of which at least 25% must be active CNV.
  • For patients with occult or non classic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks.
  • Clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening.
  • Intraocular pressure of 21 mm Hg or less.
  • Retinal thickness ≥ 250 μm by OCT.
  • Normal screening ERG
  • Normal ECG

Exclusion Criteria:

  • PDT within 120 days prior to screening in the study eye.
  • Previous therapeutic radiation to the eye.
  • Any retinovascular disease or retinal degeneration other than AMD.
  • Serous pigment epithelial detachment without the presence of neovascularization.
  • Presence of pigment epithelial tears or rips.
  • Previous posterior vitrectomy or retinal surgery.
  • Any periocular infection in the past 4 weeks.
  • Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or previous use of these agents within 60 days of screening in the study eye.
  • Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening.
  • Cataract surgery in the study eye within three months of screening.
  • Intraocular surgery in the study eye within three months of screening.
  • Presence of ocular infection in the study eye.
  • Presence of severe myopia (-8 diopters or greater) in the study eye.
  • Allergy to or prior significant adverse reaction to fluorescein.
  • Any major surgical procedure within one month of trial entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00536016

United States, California
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Research Institute
Royal Oak, Michigan, United States, 40873
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Valley Retina Institute
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Jerini Ophthalmic
Study Chair: Anthony Adamis, MD Jerini Ophthalmic

Responsible Party: Jerini Ophthalmic Identifier: NCT00536016     History of Changes
Other Study ID Numbers: JO642701
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Jerini Ophthalmic:
Neovascular Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases