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

Primary Purpose

Age-Related Macular Degeneration, Wet Age-Related Macular Degeneration, Macular Degeneration

Status

Unknown status

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

IRay

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiosurgery, radiosurgery, radiotherapy, IRay, AMD, Macular Degeneration, Wet AMD, xray, radiation, x ray, external beam radiation, Ranibizumab, Lucentis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

11 Gy IRay

16 Gy IRay

16 Gy IRay - Radiation First

24 Gy IRay

Arm Description

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

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

16 Gy IRay and Lucentis PRN (N = 13)

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

Outcomes

Primary Outcome Measures

Incidence of ocular radiation-related adverse events

Secondary Outcome Measures

Incidence of ocular adverse events

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

Percentage of subjects gaining ≥ 15 ETDRS letters

Percentage of subjects gaining ≥ 0 ETDRS letters

Mean change in ETDRS visual acuity

Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects)

Mean total number of ranibizumab injections

Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA)

Change in total lesion size by fluorescein angiography (FA)

Change in central retinal lesion thickness by optical coherence tomography (OCT)

Change in central subfield thickness by optical coherence tomography (OCT)

Full Information

NCT ID

NCT01217762

First Posted

October 5, 2010

Last Updated

January 18, 2012

Sponsor

Oraya Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01217762

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oraya Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration, Wet Age-Related Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

11 Gy IRay

Arm Type

Experimental

Arm Description

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

Arm Title

16 Gy IRay

Arm Type

Experimental

Arm Description

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

Arm Title

16 Gy IRay - Radiation First

Arm Type

Experimental

Arm Description

16 Gy IRay and Lucentis PRN (N = 13)

Arm Title

24 Gy IRay

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

IRay

Intervention Description

Low voltage stereotactic radiotherapy system

Primary Outcome Measure Information:

Title

Incidence of ocular radiation-related adverse events

Time Frame

Month 12

Secondary Outcome Measure Information:

Title

Incidence of ocular adverse events

Time Frame

Through month 60

Title

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

Title

Percentage of subjects gaining ≥ 15 ETDRS letters

Time Frame

Month 12

Title

Percentage of subjects gaining ≥ 0 ETDRS letters

Time Frame

Month 12

Title

Mean change in ETDRS visual acuity

Time Frame

Month 12

Title

Mean time to anti-VEGF retreatment following 2nd mandatory injection (excluding radiation-first subjects)

Time Frame

Month 12

Title

Mean total number of ranibizumab injections

Time Frame

Through month 12 and 24

Title

Change in choroidal neovascularization (CNV) size by fluorescein angiography (FA)

Time Frame

Month 12

Title

Change in total lesion size by fluorescein angiography (FA)

Time Frame

Month 12

Title

Change in central retinal lesion thickness by optical coherence tomography (OCT)

Time Frame

Month 12

Title

Change in central subfield thickness by optical coherence tomography (OCT)

Time Frame

Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denis O'Shaughnessy, Ph.D.

Organizational Affiliation

Oraya Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Mexico Distrito Federal

State/Province

Delegación Coyoacán

ZIP/Postal Code

04030

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

22895887

Citation

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.

Results Reference

derived

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

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