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Age-Related Macular DegenerationPhase 1NCT01217762

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

A Phase 1 study testing IRay in people with Age-Related Macular Degeneration and Wet Age-Related Macular Degeneration, run by Oraya Therapeutics, Inc. at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
IRay
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteMexico
Study dates
Jul 2008to Oct 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

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

    Mexico City, Delegación Coyoacán, 04030

Other trials in Mexico

About this study

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)

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).

Read the 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.

Being tested
IRay
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
Medical subject headings
Macular Degeneration, Eye Diseases, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IRayDevice

    Low voltage stereotactic radiotherapy system

Study groups in NCT01217762
Study groupRoleWhat they receive
11 Gy IRayExperimentalDay 0 Lucentis followed by 11 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 2)
Receives: Device: IRay
16 Gy IRayExperimentalDay 0 Lucentis followed by 16 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 27)
Receives: Device: IRay
16 Gy IRay - Radiation FirstExperimental16 Gy IRay and Lucentis PRN (N = 13)
Receives: Device: IRay
24 Gy IRayExperimentalDay 0 Lucentis followed by 24 Gy IRay, Lucentis at Month 1 and Lucentis PRN (N = 19)
Receives: Device: IRay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ocular radiation-related adverse events

    Measured: Month 12

Secondary outcomes (11)

  1. Incidence of ocular adverse events

    Measured: Through month 60

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

    Measured: Month 12

  3. Percentage of subjects gaining ≥ 15 ETDRS letters

    Measured: Month 12

  4. Percentage of subjects gaining ≥ 0 ETDRS letters

    Measured: Month 12

  5. Mean change in ETDRS visual acuity

    Measured: Month 12

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

    Measured: Month 12

  7. Mean total number of ranibizumab injections

    Measured: Through month 12 and 24

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

    Measured: Month 12

  9. Change in total lesion size by fluorescein angiography (FA)

    Measured: Month 12

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

    Measured: Month 12

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

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2010 (estimated)
  2. Study startJul 2008
  3. Primary completionOct 2010
  4. Study completionOct 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01217762
Sponsor's protocol ID
CLH001
Status last verified
Jan 2012
First submitted
5 Oct 2010
Last updated
19 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22895887

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IRay in people with Age-Related Macular Degeneration and Wet Age-Related Macular Degeneration, run by Oraya Therapeutics, Inc. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ocular radiation-related adverse events (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01217762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.

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