Radiation RetinopathyPhase 2/3NCT03238157
Steroids for Early Treatment of Radiation Retinopathy
A Phase 2/3 study testing Fluocinolone Acetonide (FA) implant in people with Radiation Retinopathy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Radiation Retinopathy
- What is being tested?
- Fluocinolone Acetonide (FA) implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Sep 2022
- Phase
- Phase 2/3
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary uveal melanoma
- 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
Who cannot join
- Iris melanoma
- Opaque media
- less than 21 years of age
- Inability to give consent
- Positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.
Read the detailed description
The purpose of the project is threefold:
- 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.
- 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.
- Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.
- Conditions
- Radiation Retinopathy
- Being tested
- Fluocinolone Acetonide (FA) implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinolone Acetonide (FA) implantDrug
Also called Steroid
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No 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. 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). |
| Intervention | Active comparator | 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. Receives: Drug: Fluocinolone Acetonide (FA) implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central subfield retinal thickness by OCT scan
Anatomic outcome
Measured: 24 months
Secondary outcomes (1)
Best corrected visual acuity
Functional outcome Best corrected Visual acuity and Visual field defect
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Feb 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation RetinopathyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun SINGH, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238157
- Sponsor's protocol ID
- NDA 201923
- Status last verified
- Aug 2021
- First submitted
- 31 Jul 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroids for Early Treatment of Radiation Retinopathy
- ClinicalTrials.gov ID
- NCT03238157
- Acronym / sponsor ID
- NDA 201923
- Conditions
- Radiation Retinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 3 Aug 2017 (actual)
- 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.
Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.
Detailed description
The purpose of the project is threefold:
- 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.
- 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.
- Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
| Arm | Type | Receives |
|---|---|---|
| Observation | No 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. 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). |
| Intervention | Active comparator | Drug: Fluocinolone Acetonide (FA) implantThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary uveal melanoma
- 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
Key exclusion criteria (5 listed)
- Iris melanoma
- Opaque media
- less than 21 years of age
- Inability to give consent
- Positive pregnancy test
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 |
|---|---|---|
| Fluocinolone Acetonide (FA) implantAlso: SteroidFluocinolone 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. | Drug | Intervention |
Primary outcome
Central subfield retinal thickness by OCT scan
Time frame: 24 months
Anatomic outcome
1 secondary outcome
Best corrected visual acuity
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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 Phase 2/3 study testing Fluocinolone Acetonide (FA) implant in people with Radiation Retinopathy, run by The Cleveland Clinic at 1 site in United States.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 Aug 2021. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Central subfield retinal thickness by OCT scan (time frame: 24 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 4 Aug 2021.