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

Age-Related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01217762
• Other study ID #: CLH001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 5, 2010
• Last updated: January 18, 2012
• Start date: July 2008
• Est. completion date: October 2014

Study information

• Verified date: January 2012
• Source: Oraya Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: Ministry of Health
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: October 2014
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Eye Diseases
• Macular Degeneration
• Neovascularization, Pathologic
• Retinal Diseases
• Wet Age-Related Macular Degeneration

Intervention

Device:
• IRay
Low voltage stereotactic radiotherapy system

Locations

Country	Name	City	State
Mexico	Asociación Para Evitar la Ceguera en México, I.A.P.	Mexico Distrito Federal	Delegación Coyoacán

Sponsors (1)

Lead Sponsor	Collaborator
Oraya Therapeutics, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

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

External Links

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