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)

This study has been completed.
Sponsor:
Information provided by:
Paloma Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01033721
First received: December 15, 2009
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Drug: Palomid 529
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Paloma Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Palomid 529
    comparison of different dosages of drug
    Other Name: P529
  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033721

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

Publications:
Responsible Party: David Sherris, Paloma Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01033721     History of Changes
Other Study ID Numbers: Paloma P529 Ocular
Study First Received: December 15, 2009
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014