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

Sponsor
Jerini Ophthalmic (Industry)
Overall Status
Completed
CT.gov ID
NCT00536016
Collaborator
(none)
36
Enrollment
9
Locations
27
Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
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 :
Sep 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability to determine the MTD [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 [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retina Vitreous Associates Medical Group Beverly Hills California United States 90211
2 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
3 William Beaumont Research Institute Royal Oak Michigan United States 40873
4 Dean McGee Eye Institute Oklahoma City Oklahoma United States 73120
5 Palmetto Retina Center West Columbia South Carolina United States 29169
6 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
7 Retina Research Institute of Texas Abilene Texas United States 79606
8 Vitreoretinal Consultants Houston Texas United States 77030
9 Valley Retina Institute McAllen Texas United States 78503

Sponsors and Collaborators

  • Jerini Ophthalmic

Investigators

  • Study Chair: Anthony Adamis, MD, Jerini Ophthalmic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00536016
Other Study ID Numbers:
  • JO642701
First Posted:
Sep 27, 2007
Last Update Posted:
Sep 21, 2010
Last Verified:
Sep 1, 2010
Keywords provided by , ,
AMD
Neovascular Age-Related Macular Degeneration
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Sep 21, 2010