Age-related Macular Degeneration Clinical Trial
Official title:
A Double-masked, Sham Controlled, Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Wet AMD Patients With Recurrent Leakage Secondary to CNV
The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2014 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: 1. Subjects must have neovascular AMD, have received at least 6 prior injections with Lucentis or Avastin and have exhibited one or more of the following: - have persisting fluid despite 3 consecutive monthly injections of anti- VEGF, or - received 4 prior injections over a 6 month period, or - received 8 prior injections over a 12 month period. 2. Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA. 3. Subjects must have a total lesion size of =12 disc areas and a CNV 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. 4. Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study. 5. Subjects must be at least 50 years of age. 6. 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. 7. Subjects must have best corrected visual acuity of 75 to 25 letters in the study eye and at least 20 letters in the fellow eye. Exclusion Criteria: 1. CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent =-8 diopters). 2. A globe axial length of <20 mm or >26 mm. 3. Evidence of uncontrolled diabetes as determined by an HbA1c of >6.5% and/or with retinal findings consistent with diabetic retinopathy. 4. Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT), or ocular photodynamic therapy in the study eye. 5. History of radiation to the head in the region of the study eye. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Università Vita-Salute Istituto Scientifico San Raffaele | Milan | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Manchester Royal Eye Hospital | Manchester |
Lead Sponsor | Collaborator |
---|---|
Oraya Therapeutics, Inc. |
Italy, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Lucentis injections during first 52 weeks | 52 weeks | No | |
Secondary | Change in mean VA | 52 weeks | No | |
Secondary | Loss/gain of letters of BCVA | week 52 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05984927 -
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05536297 -
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
|
Phase 3 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT04005352 -
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
|
Phase 3 | |
Withdrawn |
NCT02873351 -
A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration
|
Phase 2 | |
Active, not recruiting |
NCT02802657 -
Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration
|
Phase 4 | |
Not yet recruiting |
NCT02864472 -
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose
|
Phase 4 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT01445548 -
Sirolimus for Advanced Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02035722 -
Intravitreal Injections-related Anxiety
|
Phase 2/Phase 3 | |
Completed |
NCT01175395 -
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01048476 -
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01174407 -
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration
|
N/A | |
Terminated |
NCT00712491 -
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT00345176 -
Age-Related Eye Disease Study 2 (AREDS2)
|
Phase 3 | |
Completed |
NCT02140151 -
Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02555306 -
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Recruiting |
NCT04796545 -
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
|
N/A | |
Completed |
NCT03166202 -
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
|
||
Completed |
NCT01397409 -
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
|
Phase 2 |