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)

September 20, 2012 updated by: Paloma Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
43 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
43 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey S. Heier, M.D., Ophthalmic Consultants of Boston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • Paloma P529 Ocular

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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