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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

NCT ID: NCT01033721

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Palomid 529

comparison of different dosages of drug

Intervention Type DRUG

Other Intervention Names

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P529

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paloma Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Paloma Pharmaceuticals, Inc.

Principal Investigators

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Jeffrey S. Heier, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Locations

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Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19369237 (View on PubMed)

Other Identifiers

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Paloma P529 Ocular

Identifier Type: -

Identifier Source: org_study_id