NCT01217762

Brief Summary

The purpose of this study is to evaluate the safety and clinical feasibility of the IRay System for the treatment of wet age-related macular degeneration (AMD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

October 5, 2010

Last Update Submit

January 18, 2012

Conditions

Age-Related Macular DegenerationWet Age-Related Macular DegenerationMacular DegenerationEye DiseasesRetinal Diseases

Keywords

OrayaOraya Therapeutics, Inc.low voltage stereotactic radiosurgeryradiosurgeryradiotherapyIRayAMDMacular DegenerationWet AMDxrayradiationx rayexternal beam radiationRanibizumabLucentis

Outcome Measures

Primary Outcomes (1)

  • Incidence of ocular radiation-related adverse events

    Month 12

Secondary Outcomes (11)

  • Incidence of ocular adverse events

    Through month 60

  • Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA)

    Month 12

  • Percentage of subjects gaining ≥ 15 ETDRS letters

    Month 12

  • Percentage of subjects gaining ≥ 0 ETDRS letters

    Month 12

  • Mean change in ETDRS visual acuity

    Month 12

  • +6 more secondary outcomes

Study Arms (4)

11 Gy IRay

EXPERIMENTAL

Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)

Device: IRay

16 Gy IRay

EXPERIMENTAL

Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)

Device: IRay

16 Gy IRay - Radiation First

EXPERIMENTAL

16 Gy IRay and Lucentis PRN (N = 13)

Device: IRay

24 Gy IRay

EXPERIMENTAL

Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)

Device: IRay

Interventions

IRayDEVICE

Low voltage stereotactic radiotherapy system

11 Gy IRay16 Gy IRay16 Gy IRay - Radiation First24 Gy IRay

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be age 50 or older
  • Women must be post-menopausal ≥1 year or surgically sterilized
  • Subjects must have choroidal neovascularization lesion size of ≤11 total disc areas (28.26mm), and a greatest linear dimension of ≤6 mm
  • Subjects must have Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye
  • Subretinal hemorrhage (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space

You may not qualify if:

  • Subjects with prior or concurrent therapies including submacular surgery, thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy and transpupillary thermotherapy (TTT)
  • Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy,presence of RPE tears or rips, acute ocular or periocular infection
  • Subjects with advanced glaucoma (\>0.8 cup to disk ratio) or intraocular pressure ≥30 mmHg in the study eye
  • Previous glaucoma filtering surgery in the study eye
  • Refractive error in the study eye demonstrating more than -8 diopters of myopia (or globe axial length ≥26 mm). For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error cannot exceed -8 diopters of myopia
  • Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Para Evitar la Ceguera en México, I.A.P.

Mexico City, Delegación Coyoacán, 04030, Mexico

Location

Related Publications (1)

  • Moshfeghi AA, Morales-Canton V, Quiroz-Mercado H, Velez-Montoya R, Zavala-Ayala A, Shusterman EM, Kaiser PK, Sanislo SR, Gertner M, Moshfeghi DM. 16 Gy low-voltage x-ray irradiation followed by as needed ranibizumab therapy for age-related macular degeneration: 12 month outcomes of a 'radiation-first' strategy. Br J Ophthalmol. 2012 Oct;96(10):1320-4. doi: 10.1136/bjophthalmol-2011-301222. Epub 2012 Aug 15.

    PMID: 22895887DERIVED

MeSH Terms

Conditions

Macular DegenerationEye DiseasesRetinal Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration

Study Officials

  • Denis O'Shaughnessy, Ph.D.

    Oraya Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 8, 2010

Study Start

July 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2014

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

ME(1)