Trial record 2 of 969 for:    "Macular degeneration"

Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oraya Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01217762
First received: October 5, 2010
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Age-Related Macular Degeneration
Wet Age-Related Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
Device: IRay
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety and Tolerability of the IRay Stereotactic Radiosurgery System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Oraya Therapeutics, Inc.:

Primary Outcome Measures:
  • Incidence of ocular radiation-related adverse events [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of ocular adverse events [ Time Frame: Through month 60 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects who lose at least 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Percentage of subjects gaining ≥ 15 ETDRS letters [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Percentage of subjects gaining ≥ 0 ETDRS letters [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean change in ETDRS visual acuity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean total number of ranibizumab injections [ Time Frame: Through month 12 and 24 ] [ Designated as safety issue: No ]
  • Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change in total lesion size by fluorescein angiography (FA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change in central retinal lesion thickness by optical coherence tomography (OCT) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change in central subfield thickness by optical coherence tomography (OCT) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: July 2008
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11 Gy IRay
Day 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
Device: IRay
Low voltage stereotactic radiotherapy system
Experimental: 16 Gy IRay
Day 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
Device: IRay
Low voltage stereotactic radiotherapy system
Experimental: 16 Gy IRay - Radiation First
16 Gy IRay and Lucentis PRN (N = 13)
Device: IRay
Low voltage stereotactic radiotherapy system
Experimental: 24 Gy IRay
Day 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
Device: IRay
Low voltage stereotactic radiotherapy system

Detailed Description:

The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with the Oraya IRay system for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), as measured by incidence and severity of ocular radiation related serious adverse events (SAE) and adverse events (AE) in subjects treated with an 11, 16 or 24 Gray (Gy) macular dose through the 60-month follow-up visit.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217762

Locations
Mexico
Asociación Para Evitar la Ceguera en México, I.A.P.
Mexico Distrito Federal, Delegación Coyoacán, Mexico, 04030
Sponsors and Collaborators
Oraya Therapeutics, Inc.
Investigators
Study Director: Denis O'Shaughnessy, Ph.D. Oraya Therapeutics, Inc.
  More Information

No publications provided by Oraya Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oraya Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01217762     History of Changes
Other Study ID Numbers: CLH001
Study First Received: October 5, 2010
Last Updated: January 18, 2012
Health Authority: Mexico: Ethics Committee
Mexico: Ministry of Health

Keywords provided by Oraya Therapeutics, Inc.:
Macular Degeneration
Oraya
Oraya Therapeutics, Inc.
low voltage stereotactic radiosurgery
radiosurgery
radiotherapy
IRay
AMD
Wet AMD
xray
radiation
x ray
external beam radiation
Ranibizumab
Lucentis

Additional relevant MeSH terms:
Eye Diseases
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization
Retinal Degeneration
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on April 20, 2014