NCT00536016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

September 25, 2007

Last Update Submit

September 20, 2010

Conditions

Macular Degeneration

Keywords

AMDNeovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability to determine the MTD

    2 weeks after each dose

Secondary Outcomes (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

Interventions

JSM6427DRUG

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.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

William Beaumont Research Institute

Royal Oak, Michigan, 40873, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73120, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

JSM6427

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Anthony Adamis, MD

    Jerini Ophthalmic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(9)