Phase I Study of Palomid 529 a Dual TORC1/2 Inhibitor of the PI3K/Akt/mTOR Pathway for Advanced Neovascular Age-Related Macular Degeneration (P52901)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033721
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : September 24, 2012
Information provided by:
Paloma Pharmaceuticals, Inc.

Brief Summary:
Palomid 529 is a dual TORC1/2 inhibitor of the PI3K/Akt/mTOR pathway having broad activity in angiogenesis and cellular proliferation. Palomid 529 will be examined to determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Palomid 529 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single Intravitreal and Subconjunctival Doses of Palomid 529 in Patients With Advanced Neovascular Age-Related Macular Degeneration (AMD)
Study Start Date : June 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Palomid 529
    comparison of different dosages of drug
    Other Name: P529

Primary Outcome Measures :
  1. Safety-Review AEs, concomitant meds-Vitals, HR, systolic/diastolic BP, temperature, weight-ECG changes; Physical exam-Laboratory parameters-Ophthalmic exam-visual acuity, IOP, slit lamp fundus exam, fundus photography, fluorescein angiography, OCT [ Time Frame: 43 days ]

Secondary Outcome Measures :
  1. Efficacy-Mean change in visual acuity by ETDRS testing-Decreased leakage and/or size on FA, decreased retinal thickness in OCT-Decreased fibrosis if detectable based on fundus examination, photography, angiography and OCT [ Time Frame: 43 days ]

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Best corrected visual acuity in the study eye between 20/100 and 20/800 (between 53 and 4 ETDRS letters read), and better or equal to 20/200 (minimum of 34 letters read) in the fellow eye.
  • Subfoveal choroidal neovascularization (CNV) due to AMD
  • Total area of the lesion (including blood, neovascularization and scar/atrophy) must be < 12 DA.
  • Only 1 eye will be treated in the study. If both eyes are eligible, the investigator will select the eye with the most active CNV
  • 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, with presence of intraretinal or subretinal fluid

Exclusion Criteria:

  • Any retinovascular disease or retinal degeneration other than AMD
  • Serous pigment epithelial detachment without the presence of neovascularization
  • 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
  • Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening
  • Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography
  • Cataract surgery in the study eye within 3 months of screening
  • Intraocular surgery in the study eye within 3 months of screening
  • Presence of ocular infection in the study eye
  • Presence of severe myopia (-8 diopters or greater) in the study eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01033721

United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Paloma Pharmaceuticals, Inc.
Principal Investigator: Jeffrey S. Heier, M.D. Ophthalmic Consultants of Boston

Responsible Party: David Sherris, Paloma Pharmaceuticals, Inc. Identifier: NCT01033721     History of Changes
Other Study ID Numbers: Paloma P529 Ocular
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

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