Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2022-02-01
2022-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment
NCT05031143
Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina
NCT02088151
Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders
NCT00071227
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
NCT04847635
Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
NCT03944239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA.
2. Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial.
3. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Observation
The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of \>40 Gy to the center of the macula. These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care).
No interventions assigned to this group
Intervention
The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of \>40 Gy to the center of the macula.1 These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.
Fluocinolone Acetonide (FA) implant
Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluocinolone Acetonide (FA) implant
Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Primary treatment with plaque brachytherapy
* Baseline visual acuity 20/200 or better
* Posterior tumor margin \>1.50 mm from the center of the macula
* Posterior tumor margin \> 1.50 mm from the closest disc margin
* Calculated total dose to center of the macula \>40 Gy
Exclusion Criteria
* Opaque media
* less than 21 years of age
* Inability to give consent
* Positive pregnancy test
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Cleveland Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arun SINGH
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cole Eye Instiute
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NDA 201923
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.