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

This study has been completed.
Sponsor:
Information provided by:
Jerini Ophthalmic
ClinicalTrials.gov Identifier:
NCT00536016
First received: September 25, 2007
Last updated: September 20, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Macular Degeneration
Drug: JSM6427
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jerini Ophthalmic:

Primary Outcome Measures:
  • Safety and Tolerability to determine the MTD [ Time Frame: 2 weeks after each dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536016

Locations
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
Investigators
Study Chair: Anthony Adamis, MD Jerini Ophthalmic
  More Information

No publications provided

Responsible Party: Jerini Ophthalmic
ClinicalTrials.gov Identifier: NCT00536016     History of Changes
Other Study ID Numbers: JO642701
Study First Received: September 25, 2007
Last Updated: September 20, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014