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A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
This study is currently recruiting participants.
Verified by Jerini Ophthalmic, June 2008
Sponsored by: Jerini Ophthalmic
Information provided by: Jerini Ophthalmic
ClinicalTrials.gov Identifier: NCT00536016
  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 I

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: JSM6427
    Intravitreal Injection of drug in concentrations of 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml or 15 mg/ml
    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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536016

Contacts
Contact: Adrienne Berman, MD 949-759-1004 iolite.consulting@gmail.com
Contact: Robert Miller, MD (919) 226 1440 ext 325 Robert.Miller@fulcrumpharma.com

Locations
United States, California
Retina Vitreous Associates Medical Group Not yet recruiting
Beverly Hills, California, United States, 90211
Contact: Janet Kurokoushi     310-652-1956     jkurokoushi@msn.com    
Principal Investigator: David Boyer, MD            
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emily Corey     617-314-2608     ecorey@eyeboston.com    
Principal Investigator: Jeffrey Heier, MD            
United States, Michigan
William Beaumont Research Institute Recruiting
Royal Oak, Michigan, United States, 40873
Contact: Tammy Osentowski, BSN     248-551-9866     Tosentowski@beaumont.edu    
Principal Investigator: George A. Williams, MD            
United States, Oklahoma
Dean McGee Eye Institute Not yet recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Misty Youngberg     405-271-6307     misty-youngberg@dmei.org    
Principal Investigator: Robert Leonard, MD            
United States, South Carolina
Palmetto Retina Center Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Mallie Taylor     803-744-0144     mtaylor@palmettoretina.com    
Principal Investigator: John Wells, MD            
United States, South Dakota
Black Hills Regional Eye Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Honor Evers     605-719-3308     hevers@bhrei.com    
Principal Investigator: Prema Abraham, MD            
United States, Texas
Valley Retina Institute Recruiting
McAllen, Texas, United States, 78503
Contact: Aaron Guel     956-631-8875     aag@vritx.com    
Principal Investigator: Victor Gonzalez, MD            
Retina Research Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Contact: Angela Jaimes     325-690-4414     angela@westtexasretina.com    
Principal Investigator: Sunil Patel, MD            
Vitreoretinal Consultants Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jolene Carranza         jolene.carranza@houstonretina.com    
Principal Investigator: David Brown, MD            
Sponsors and Collaborators
Jerini Ophthalmic
Investigators
Study Chair: Anthony Adamis, MD Jerini Ophthalmic
  More Information

Responsible Party: Jerini Ophthalmic ( Anthony Adamis, MD CEO and President )
Study ID Numbers: JO642701
Study First Received: September 25, 2007
Last Updated: June 12, 2008
ClinicalTrials.gov Identifier: NCT00536016  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 15, 2009