search
Back to results

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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JSM6427
Sponsored by
Jerini Ophthalmic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Neovascular Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Vitreous Associates Medical Group
  • Ophthalmic Consultants of Boston
  • William Beaumont Research Institute
  • Dean McGee Eye Institute
  • Palmetto Retina Center
  • Black Hills Regional Eye Institute
  • Retina Research Institute of Texas
  • Vitreoretinal Consultants
  • Valley Retina Institute

Outcomes

Primary Outcome Measures

Safety and Tolerability to determine the MTD

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

Full Information

First Posted
September 25, 2007
Last Updated
September 20, 2010
Sponsor
Jerini Ophthalmic
search

1. Study Identification

Unique Protocol Identification Number
NCT00536016
Brief Title
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jerini Ophthalmic

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Neovascular Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
JSM6427
Intervention Description
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 Measure Information:
Title
Safety and Tolerability to determine the MTD
Time Frame
2 weeks after each dose
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Adamis, MD
Organizational Affiliation
Jerini Ophthalmic
Official's Role
Study Chair
Facility Information:
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
40873
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs