Retinal Pigment Epithelial Detachment With VascularizationNCT01521819
Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degeneration
A study testing Iray and Lucentis in people with Retinal Pigment Epithelial Detachment With Vascularization and Age Related Macular Degeneration, run by Oraya Therapeutics, Inc. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Retinal Pigment Epithelial Detachment With Vascularization, Age Related Macular Degeneration
- What is being tested?
- Iray and Lucentis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- 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
- 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).
Who cannot join
- 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.
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- 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).
- Currently receiving chemotherapy, having completed a course within the 90 days preceding study enrollment, or expecting to begin chemotherapy while participating in the study.
- Current participation in another drug or device clinical trial.
- History of use of drugs with known retinal toxicity, including: chloroquine (Aralen - antimalarial), hydroxychloriquine (Plaquenil - antimalarial), phenothiazines (Thorazine, Stelazine, Mellaril, Prolixin, Trilafon, etc., - tranquilizing antipsychotic medications) and these patients are exhibiting signs of retinal toxicity.
- Concurrent use of systemic anti-VEGF agents.
- Any other condition, which in the judgment of the investigator would prevent the subject from granting consent or completing the study, such as dementia, mental illness (including generalized anxiety disorder, claustrophobia, etc.), or inability to position in the device (due to musculoskeletal problems, etc.).
- History of other significant, uncontrolled disease including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal, metabolic dysfunction, any clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of intravitreal ranibizumab or that might affect interpretation of the results of the study or render the subject at high risk for treatment complication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Vascularized Pigment Epithelial Detachment (V-PED) Secondary to AMD With Serous Component Superior to 50% of the Lesion Will Receive Low Voltage Stereotactic Radiotherapy (IRay®) Treatment and Lucentis Treatment as Needed.
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.
Read the detailed description
This study will evaluate the efficacy of IRay treatment in patients with Vascularized Pigment Epithelial Detachment (V-PED) with serous component superior to 50% of the lesion as determined by decreasing the lesion activity; by decreasing the number of Lucentis injections required during the 12 month study.
- Conditions
- Retinal Pigment Epithelial Detachment With Vascularization, Age Related Macular Degeneration
- Being tested
- Iray, Lucentis
- Keywords
- AMD, V-Ped, Vascularized Pigment Epithelial Detachment, Iray, radiation, retina, macula, radiotherapy
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrayRadiation
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.
LucentisDrug
Intravitreal injection of Lucentis as needed.
| Study group | Role | What they receive |
|---|---|---|
| Iray plus Lucentis | Experimental | open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis. Receives: Radiation: Iray; Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion change as measured with fluorescein angiography.
Change in the proportion of the lesion which is active at 12 months.
Measured: Baseline and 12 months
Secondary outcomes (2)
Number of Lucentis injections
Number of Lucentis injections during 12 months
Measured: Baseline and 12 months
Visual Acuity change
Mean change in visual acuity
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Pigment Epithelial Detachment With VascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oraya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521819
- Sponsor's protocol ID
- CLH006
- Status last verified
- Oct 2012
- First submitted
- 24 Jan 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Vascularized Pigment Epithelial Detachment (V-PED) Secondary to AMD With Serous Component Superior to 50% of the Lesion Will Receive Low Voltage Stereotactic Radiotherapy (IRay®) Treatment and Lucentis Treatment as Needed.
- ClinicalTrials.gov ID
- NCT01521819
- Acronym / sponsor ID
- CLH006
- Conditions
- Retinal Pigment Epithelial Detachment With Vascularization, Age Related Macular Degeneration
- Keywords
- AMD, V-Ped, Vascularized Pigment Epithelial Detachment, Iray, radiation, retina, macula, radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Oraya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will evaluate the efficacy of IRay treatment in patients with Vascularized Pigment Epithelial Detachment (V-PED) with serous component superior to 50% of the lesion as determined by decreasing the lesion activity; by decreasing the number of Lucentis injections required during the 12 month study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iray plus Lucentis | Experimental | Radiation: Iray, Drug: Lucentisopen label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrayThe 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. | Radiation | Iray plus Lucentis |
| LucentisIntravitreal injection of Lucentis as needed. | Drug | Iray plus Lucentis |
Primary outcome
Lesion change as measured with fluorescein angiography.
Time frame: Baseline and 12 months
Change in the proportion of the lesion which is active at 12 months.
2 secondary outcomes
Number of Lucentis injections
Time frame: Baseline and 12 months
Visual Acuity change
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iray and Lucentis in people with Retinal Pigment Epithelial Detachment With Vascularization and Age Related Macular Degeneration, run by Oraya Therapeutics, Inc. at 1 site in Italy.
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 8 inclusion and 21 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 25 Oct 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 Italy. 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.
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?
Lesion change as measured with fluorescein angiography. (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2012.