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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)

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Palomid 529
Sponsored by
Paloma Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for 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 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

Sites / Locations

  • Ophthalmic Consultants of Boston

Outcomes

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

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

Full Information

First Posted
December 15, 2009
Last Updated
September 20, 2012
Sponsor
Paloma Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01033721
Brief Title
Phase I Study of Palomid 529 a Dual TORC1/2 Inhibitor of the PI3K/Akt/mTOR Pathway for Advanced Neovascular Age-Related Macular Degeneration
Acronym
P52901
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Paloma Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Palomid 529
Other Intervention Name(s)
P529
Intervention Description
comparison of different dosages of drug
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Heier, M.D.
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19369237
Citation
Lewis GP, Chapin EA, Byun J, Luna G, Sherris D, Fisher SK. Muller cell reactivity and photoreceptor cell death are reduced after experimental retinal detachment using an inhibitor of the Akt/mTOR pathway. Invest Ophthalmol Vis Sci. 2009 Sep;50(9):4429-35. doi: 10.1167/iovs.09-3445. Epub 2009 Apr 15.
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Phase I Study of Palomid 529 a Dual TORC1/2 Inhibitor of the PI3K/Akt/mTOR Pathway for Advanced Neovascular Age-Related Macular Degeneration

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