Exudative Retinal Detachment and Uveal MelanomaPhase 1NCT04082962
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
A Phase 1 study testing Dexamethasone intravitreal implant in people with Exudative Retinal Detachment and Uveal Melanoma, run by Ivana K. Kim at 1 site in United States.
Trial summary
This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exudative Retinal Detachment and Uveal Melanoma
- What is being tested?
- Dexamethasone intravitreal implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 7 Dec 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor thickness <= 10 mm.
- Associated serous retinal detachment extending beyond tumor, > two clockhours in extent.
- Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.
Who cannot join
- Any pre-existing glaucoma.
- History of elevated IOP (> 25 mm Hg).
- History of steroid response glaucoma.
- Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Any history of ocular herpes simplex.
- Torn or ruptured posterior lens capsule.
- Known hypersensitivity to any components of the dexamethasone intravitreal implant.
- Women of child-bearing potential: pregnant or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision loss. Effective treatments for ERD are currently lacking. We are conducting this study to evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not approved for use in patients with UM and ERD. This study will determine the safety of the dexamethasone implant and provide preliminary evidence of efficacy in this population.
Read the detailed description
Study Objective: The primary objective of the study will be to determine the safety of the Ozurdex (dexamethasone) intravitreal implant. The secondary objective is to determine if the implant helps to resolve exudative retinal detachment, a secondary complication associated with uveal melanoma.
Background: This is a single site investigator-initiated Phase I study of a single dose of intravitreally administered dexamethasone implant (Ozurdex™) in subjects with choroidal melanomas and exudative retinal detachments being treated with proton beam irradiation or plaque radiation therapy. This is one of the first studies to evaluate the Ozurdex™ implant in this setting. Therefore the primary goal is to evaluate safety.
Patient Population: Twenty patients will be enrolled in this randomized pilot study. Patients must meet the following eligibility criteria to enroll: Tumor thickness ≤ 10 mm, associated serous retinal detachment > two clock hours in extent, primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy. Males and females >18 years of age are eligible.
Methods: Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (< 5mm and 5mm - ≤ 10 mm). Patients will be masked to their treatment assignment.
Patients will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at either (1) the time of their tumor localization (tantalum ring placement) surgery before proton therapy or (2) their surgery removing the plaque following plaque radiotherapy. A sham treatment procedure to maintain the mask will be unnecessary.
Patients will be followed at 6 weeks, 14 weeks, 28 weeks and 54 weeks after administration of the dexamethasone implant. Visual acuity, intraocular pressure, optical coherence tomography, B-scan ultrasonography, wide-angle color photography and full ophthalmological examination will be performed pre-op and on every follow-up visit. Evaluation of adverse events and review of medical history and medication use will be completed at all follow-up visits.
The primary outcome of the study will be to evaluate the safety of the implant. This will be done by monitoring for all adverse effects not related to the melanoma or radiation treatment including significant vision loss, other sight-threatening events, and unforeseen systemic events.
Secondary endpoints include resolution of retinal detachment at 6 and 12 months after implant insertion, visual acuity at 6 and 12 months after implant insertion, and development of iris neovascularization and neovascular glaucoma during the 12 month study period.
Statistical Analysis Plan: There is no formal sample size calculation in a pilot/phase I study. As this is a phase I study, a sample size of 20 patients is chosen, making sure that it is feasible financially and logistically to conduct the study.
Safety Endpoints: Incidence and severity of ocular and systemic adverse events identified by ocular examination, diagnostic tests, and subject reporting will be summarized. Comparisons of these endpoints of study subjects who received treatment may be made with those of control subjects, matched on prognostic factors including tumor size and tumor location. The proportion of treated patients with adverse events will be tabulated by body system, stratified by tumor size and location, and compared to patients in the control arm using Fisher's exact test and other appropriate tests of association.
Efficacy Endpoints: Descriptive statistics will be generated to assess resolution of exudative retinal detachment at 6 months after placement of the Ozurdex implant or no treatment. This is the most important efficacy endpoint. Descriptive statistics will be generated for the following secondary efficacy endpoints: incidence of neovascular glaucoma, incidence of rubeosis, percent of patients with exudative retinal detachment at 12 months, and distribution of visual acuity measures at 6 months and 12 months. All measures will be compared between patients in the treatment arm and those in the control arm of the study.
- Being tested
- Dexamethasone intravitreal implant
- Keywords
- Dexamethasone, Uveal Melanoma, Steroid-Implant, Exudative Retinal Detachment
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone intravitreal implantDrug
Also called Ozurdex™
Ozurdex™ is an intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system (NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix, which slowly degrades to lactic acid and glycolic acid.). Ozurdex™ is preservative-free. It is supplied in a foil pouch with a single-use plastic applicator.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants receiving dexamethasone implant. Receives: Drug: Dexamethasone intravitreal implant |
| Non-treatment group (control) | No intervention | Participants not receiving dexamethasone implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events Related to the Implant
The primary outcome of the study will be to evaluate the safety of the implant. All adverse effects not related to the melanoma or radiation treatment identified by ocular examination, diagnostic tests, and subject reporting will be tabulated. This includes significant vision loss, other sight-threatening events, and unforeseen systemic events.
Measured: Throughout 12 month study period
Secondary outcomes (3)
Exudative retinal detachment resolution
Will be assessed using spectral domain optical coherence tomography, B-scan ultrasonography, and Optos wide-angle color photography.
Measured: 6 and 12 months after implant insertion
Visual Acuity
Measured with ETDRS chart.
Measured: 6 and 12 months after implant insertion
Complications
The development of iris neovascularization and neovascular glaucoma.
Measured: Throughout 12 month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start11 Dec 2018
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Exudative Retinal Detachment and Uveal MelanomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty patients will be enrolled in this randomized pilot study. Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (\< 5mm and 5mm - \< 10 mm). Patients with newly diagnosed choroidal melanoma meeting specified eligibility criteria will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at the time of their tumor localization (tantalum ring placement) surgery for patients receiving PBI or at the time of plaque removal for those patients receiving plaque radiotherapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivana K. Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivana K. Kim, Massachusetts Eye and Ear Infirmary
- Investigators
- Ivana K Kim, MD, Principal investigator, Harvard Medical School, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082962
- Sponsor's protocol ID
- 2019P000127
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2019
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scotto J, Fraumeni JF Jr, Lee JA. Melanomas of the eye and other noncutaneous sites: epidemiologic aspects. J Natl Cancer Inst. 1976 Mar;56(3):489-91. doi: 10.1093/jnci/56.3.489.
PubMed 1255781Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year mortality rates and prognostic factors: COMS report No. 28. Arch Ophthalmol. 2006 Dec;124(12):1684-93. doi: 10.1001/archopht.124.12.1684.
PubMed 17159027Gragoudas ES. Proton beam irradiation of uveal melanomas: the first 30 years. The Weisenfeld Lecture. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4666-73. doi: 10.1167/iovs.06-0659. No abstract available.
PubMed 17065472Kivela T, Eskelin S, Makitie T, Summanen P. Exudative retinal detachment from malignant uveal melanoma: predictors and prognostic significance. Invest Ophthalmol Vis Sci. 2001 Aug;42(9):2085-93.
PubMed 11481276Gibran SK, Kapoor KG. Management of exudative retinal detachment in choroidal melanoma. Clin Exp Ophthalmol. 2009 Sep;37(7):654-9. doi: 10.1111/j.1442-9071.2009.02127.x.
PubMed 19788660Char DH, Bove R, Phillips TL. Laser and proton radiation to reduce uveal melanoma-associated exudative retinal detachments. Am J Ophthalmol. 2003 Jul;136(1):180-2.
PubMed 12834689Parrozzani R, Pilotto E, Dario A, Miglionico G, Midena E. Intravitreal triamcinolone versus intravitreal bevacizumab in the treatment of exudative retinal detachment secondary to posterior uveal melanoma. Am J Ophthalmol. 2013 Jan;155(1):127-133.e2. doi: 10.1016/j.ajo.2012.06.026. Epub 2012 Sep 18.
PubMed 22995029Kim IK, Lane AM, Jain P, Awh C, Gragoudas ES. Ranibizumab for the Prevention of Radiation Complications in Patients Treated With Proton Beam Irradiation for Choroidal Melanoma. Trans Am Ophthalmol Soc. 2016 Aug;114:T2.
PubMed 27630373Malcles A, Nguyen AM, Mathis T, Grange JD, Kodjikian L. Intravitreal dexamethasone implant (Ozurdex(R)) for exudative retinal detachment after proton beam therapy for choroidal melanoma. Eur J Ophthalmol. 2017 Aug 30;27(5):596-600. doi: 10.5301/ejo.5000940. Epub 2017 Feb 8.
PubMed 28218368Koehler PJ. Use of corticosteroids in neuro-oncology. Anticancer Drugs. 1995 Feb;6(1):19-33. doi: 10.1097/00001813-199502000-00002.
PubMed 7756680Sturdza A, Millar BA, Bana N, Laperriere N, Pond G, Wong RK, Bezjak A. The use and toxicity of steroids in the management of patients with brain metastases. Support Care Cancer. 2008 Sep;16(9):1041-8. doi: 10.1007/s00520-007-0395-8. Epub 2008 Feb 7.
PubMed 18256860
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
- ClinicalTrials.gov ID
- NCT04082962
- Acronym / sponsor ID
- 2019P000127
- Keywords
- Dexamethasone, Uveal Melanoma, Steroid-Implant, Exudative Retinal Detachment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ivana K. KimUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 10 Sep 2019 (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.
This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision loss. Effective treatments for ERD are currently lacking. We are conducting this study to evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not approved for use in patients with UM and ERD. This study will determine the safety of the dexamethasone implant and provide preliminary evidence of efficacy in this population.
Detailed description
Study Objective: The primary objective of the study will be to determine the safety of the Ozurdex (dexamethasone) intravitreal implant. The secondary objective is to determine if the implant helps to resolve exudative retinal detachment, a secondary complication associated with uveal melanoma.
Background: This is a single site investigator-initiated Phase I study of a single dose of intravitreally administered dexamethasone implant (Ozurdex™) in subjects with choroidal melanomas and exudative retinal detachments being treated with proton beam irradiation or plaque radiation therapy. This is one of the first studies to evaluate the Ozurdex™ implant in this setting. Therefore the primary goal is to evaluate safety.
Patient Population: Twenty patients will be enrolled in this randomized pilot study. Patients must meet the following eligibility criteria to enroll: Tumor thickness ≤ 10 mm, associated serous retinal detachment > two clock hours in extent, primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy. Males and females >18 years of age are eligible.
Methods: Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (< 5mm and 5mm - ≤ 10 mm). Patients will be masked to their treatment assignment.
Patients will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at either (1) the time of their tumor localization (tantalum ring placement) surgery before proton therapy or (2) their surgery removing the plaque following plaque radiotherapy. A sham treatment procedure to maintain the mask will be unnecessary.
Patients will be followed at 6 weeks, 14 weeks, 28 weeks and 54 weeks after administration of the dexamethasone implant. Visual acuity, intraocular pressure, optical coherence tomography, B-scan ultrasonography, wide-angle color photography and full ophthalmological examination will be performed pre-op and on every follow-up visit. Evaluation of adverse events and review of medical history and medication use will be completed at all follow-up visits.
The primary outcome of the study will be to evaluate the safety of the implant. This will be done by monitoring for all adverse effects not related to the melanoma or radiation treatment including significant vision loss, other sight-threatening events, and unforeseen systemic events.
Secondary endpoints include resolution of retinal detachment at 6 and 12 months after implant insertion, visual acuity at 6 and 12 months after implant insertion, and development of iris neovascularization and neovascular glaucoma during the 12 month study period.
Statistical Analysis Plan: There is no formal sample size calculation in a pilot/phase I study. As this is a phase I study, a sample size of 20 patients is chosen, making sure that it is feasible financially and logistically to conduct the study.
Safety Endpoints: Incidence and severity of ocular and systemic adverse events identified by ocular examination, diagnostic tests, and subject reporting will be summarized. Comparisons of these endpoints of study subjects who received treatment may be made with those of control subjects, matched on prognostic factors including tumor size and tumor location. The proportion of treated patients with adverse events will be tabulated by body system, stratified by tumor size and location, and compared to patients in the control arm using Fisher's exact test and other appropriate tests of association.
Efficacy Endpoints: Descriptive statistics will be generated to assess resolution of exudative retinal detachment at 6 months after placement of the Ozurdex implant or no treatment. This is the most important efficacy endpoint. Descriptive statistics will be generated for the following secondary efficacy endpoints: incidence of neovascular glaucoma, incidence of rubeosis, percent of patients with exudative retinal detachment at 12 months, and distribution of visual acuity measures at 6 months and 12 months. All measures will be compared between patients in the treatment arm and those in the control arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Twenty patients will be enrolled in this randomized pilot study. Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (< 5mm and 5mm - < 10 mm). Patients with newly diagnosed choroidal melanoma meeting specified eligibility criteria will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at the time of their tumor localization (tantalum ring placement) surgery for patients receiving PBI or at the time of plaque removal for those patients receiving plaque radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Dexamethasone intravitreal implantParticipants receiving dexamethasone implant. |
| Non-treatment group (control) | No intervention | –Participants not receiving dexamethasone implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tumor thickness <= 10 mm.
- Associated serous retinal detachment extending beyond tumor, > two clockhours in extent.
- Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.
Key exclusion criteria (8 listed)
- Any pre-existing glaucoma.
- History of elevated IOP (> 25 mm Hg).
- History of steroid response glaucoma.
- Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Any history of ocular herpes simplex.
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 |
|---|---|---|
| Dexamethasone intravitreal implantAlso: Ozurdex™Ozurdex™ is an intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system (NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix, which slowly degrades to lactic acid and glycolic acid.). Ozurdex™ is preservative-free. It is supplied in a foil pouch with a single-use plastic applicator. | Drug | Treatment Group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events Related to the Implant
Time frame: Throughout 12 month study period
The primary outcome of the study will be to evaluate the safety of the implant. All adverse effects not related to the melanoma or radiation treatment identified by ocular examination, diagnostic tests, and subject reporting will be tabulated. This includes significant vision loss, other sight-threatening events, and unforeseen systemic events.
3 secondary outcomes
Exudative retinal detachment resolution
Time frame: 6 and 12 months after implant insertion
Visual Acuity
Time frame: 6 and 12 months after implant insertion
Complications
Time frame: Throughout 12 month study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 1255781Scotto J, Fraumeni JF Jr, Lee JA. Melanomas of the eye and other noncutaneous sites: epidemiologic aspects. J Natl Cancer Inst. 1976 Mar;56(3):489-91. doi: 10.1093/jnci/56.3.489.
- Background: PubMed 17159027Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year mortality rates and prognostic factors: COMS report No. 28. Arch Ophthalmol. 2006 Dec;124(12):1684-93. doi: 10.1001/archopht.124.12.1684.
- Background: PubMed 17065472Gragoudas ES. Proton beam irradiation of uveal melanomas: the first 30 years. The Weisenfeld Lecture. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4666-73. doi: 10.1167/iovs.06-0659. No abstract available.
- Background: PubMed 11481276Kivela T, Eskelin S, Makitie T, Summanen P. Exudative retinal detachment from malignant uveal melanoma: predictors and prognostic significance. Invest Ophthalmol Vis Sci. 2001 Aug;42(9):2085-93.
- Background: PubMed 19788660Gibran SK, Kapoor KG. Management of exudative retinal detachment in choroidal melanoma. Clin Exp Ophthalmol. 2009 Sep;37(7):654-9. doi: 10.1111/j.1442-9071.2009.02127.x.
- Background: PubMed 12834689Char DH, Bove R, Phillips TL. Laser and proton radiation to reduce uveal melanoma-associated exudative retinal detachments. Am J Ophthalmol. 2003 Jul;136(1):180-2.
- Background: PubMed 22995029Parrozzani R, Pilotto E, Dario A, Miglionico G, Midena E. Intravitreal triamcinolone versus intravitreal bevacizumab in the treatment of exudative retinal detachment secondary to posterior uveal melanoma. Am J Ophthalmol. 2013 Jan;155(1):127-133.e2. doi: 10.1016/j.ajo.2012.06.026. Epub 2012 Sep 18.
- Background: PubMed 27630373Kim IK, Lane AM, Jain P, Awh C, Gragoudas ES. Ranibizumab for the Prevention of Radiation Complications in Patients Treated With Proton Beam Irradiation for Choroidal Melanoma. Trans Am Ophthalmol Soc. 2016 Aug;114:T2.
- Background: PubMed 28218368Malcles A, Nguyen AM, Mathis T, Grange JD, Kodjikian L. Intravitreal dexamethasone implant (Ozurdex(R)) for exudative retinal detachment after proton beam therapy for choroidal melanoma. Eur J Ophthalmol. 2017 Aug 30;27(5):596-600. doi: 10.5301/ejo.5000940. Epub 2017 Feb 8.
- Background: PubMed 7756680Koehler PJ. Use of corticosteroids in neuro-oncology. Anticancer Drugs. 1995 Feb;6(1):19-33. doi: 10.1097/00001813-199502000-00002.
- Background: PubMed 18256860Sturdza A, Millar BA, Bana N, Laperriere N, Pond G, Wong RK, Bezjak A. The use and toxicity of steroids in the management of patients with brain metastases. Support Care Cancer. 2008 Sep;16(9):1041-8. doi: 10.1007/s00520-007-0395-8. Epub 2008 Feb 7.
- Individual participant dataSharing planned: No
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.
Ivana K Kim, MD principal investigator
Harvard Medical School, Massachusetts Eye and Ear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone intravitreal implant in people with Exudative Retinal Detachment and Uveal Melanoma, run by Ivana K. Kim 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Dec 2025. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events Related to the Implant (time frame: Throughout 12 month study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082962, which also lists 11 linked publications.
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 17 Dec 2025.