Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degeneration

NCT01521819 | Unknown DMC

• 1 other identifier: CLH006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot, single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.

Conditions

Retinal Pigment Epithelial Detachment With Vascularization; Age Related Macular Degeneration

Keywords

AMD; V-Ped; Vascularized Pigment Epithelial Detachment; Iray; radiation; retina; macula; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Lesion change as measured with fluorescein angiography.

  Change in the proportion of the lesion which is active at 12 months.

  Baseline and 12 months

Secondary Outcomes (2)

• Number of Lucentis injections

  Baseline and 12 months

• Visual Acuity change

  Baseline and 12 months

Study Arms (1)

Iray plus Lucentis

EXPERIMENTAL

open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis.

Radiation: Iray; Drug: Lucentis

Interventions

Iray RADIATION

The Oraya IRay stereotactic radiotherapy device will be used to deliver a 16 Gy dose of radiation to the macula. The radiotherapy will be delivered in a single session utilizing three sequential beams, each depositing 5.3 Gy at the macula through calculated scleral entry points, crossing the pars plana region of the eye, and overlapping at the same region of the macula.

Iray plus Lucentis

Lucentis DRUG

Intravitreal injection of Lucentis as needed.

Iray plus Lucentis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with V-PED with serous component comprising greater than 50% of the lesion area, naïve or previously treated with Lucentis® injections and Photodynamic therapy (PDT) using VisudyneÒ.
• Must have a total lesion size of \< 12 disc areas and a lesion with the greatest linear dimension of \< 6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter.
• The distance from the center of the fovea to the nearest edge of the optic disc should be not less than 3 mm. (This distance is confirmed by Oraya software prior to treatment.).
• Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
• Must be willing and able to return for scheduled treatment and follow-up examinations for the 1-year duration of the study.
• Must be at least 50 years of age.
• Women must be post-menopausal ≥ 1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study.
• Must have best corrected visual acuity of 75 to 25 letters (inclusive) in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).

You may not qualify if:

• CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent \_-8 diopters).
• A globe axial length of \< 20 mm or \> 26 mm.
• Evidence of diabetes or with retinal findings consistent with diabetic retinopathy or retinopathy for any cause.
• Hypertension that is not controlled with anti-hypertensive medication.
• Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), or transpupillary thermotherapy (TTT).
• History of radiation to the head in the region of the study eye.
• Previous posterior vitrectomy at any time, YAG capsulotomy or cataract surgery within 3 months, or any other surgery in the study eye within 6 months prior to the screening visit.
• Intravitreal device in the study eye.
• Concomitant disease in the study eye which might interfere with the effect of assessment of the study treatment, including uveitis, acute ocular or periocular infection, retinal vasculopathies (including retinal vein occlusions, etc.) or intraocular pressure \> 30 mmHg uncontrollable with medications.
• History of rhegmatogenous retina detachment, optic neuritis or intraocular tumors in the study eye.
• Inadequate pupillary dilation, significant media opacities, or other conditions in the study eye, including cataract, which may interfere with visual acuity or the evaluation of the posterior segment. Subjects likely to need cataract surgery during the 1 year study period should also not be enrolled.
• Known serious allergies to fluorescein dye used in angiography.
• Subjects must not have subretinal hemorrhage or Retinal Pigment Epithelium tear involving the center of the foveal avascular zone.
• Known sensitivity or allergy to Lucentis, or any other drug used in the study, such as topical anesthetic, cycloplegic mydriatics, or lubricating eye gel.
• Contraindication or sensitivity to contact lens application (i.e. corneal dystrophies and recurrent corneal erosions).

Sponsors & Collaborators

• Oraya Therapeutics, Inc.: lead

Study Sites (1)

Università Vita-Salute Istituto Scientifico San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 31, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

IT (1)