Macular EdemaPhase 1NCT04120311
Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
A Phase 1 study testing Episcleral Dexamethasone in people with Macular Edema and Radiation Retinopathy, run by Targeted Therapy Technologies, LLC at 1 site in United States.
Trial summary
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion
- What is being tested?
- Episcleral Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Sep 2024
- 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
- Age >= 18 years;
- Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
- Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF);
- Inflammatory disorders of the sclera, choroid, retina or vitreous
Who cannot join
- Inability to understand informed consent, cooperate with testing or return to follow up visits;
- Pregnant or lactating women;
- Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Medicine Ophthalmology
Palo Alto, California, 94303
About this study
Official title: Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
Read the detailed description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.
- Conditions
- Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy With Pit of Optic Disc, Commotio Retinae
- Being tested
- Episcleral Dexamethasone
- Keywords
- Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy with Pit of Optic Disc, Commotio Retinae, Vitritis
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion, Epiretinal Membrane, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episcleral DexamethasoneDrug
Also called Sequestered Transscleral, Controlled-Release Dexamethasone, Sustained Release Transscleral Dexamethasone
Sustained Release Episcleral Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Phase I open label study | Experimental | Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone
Other Names:
• Sustained Release Transscleral Dexamethasone Receives: Drug: Episcleral Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Assessment of ocular safety as measured by comprehensive ophthalmic exam.
Measured: 12 Months
Secondary outcomes (2)
A secondary outcome is assessment of visual acuity.
Secondary outcome is assessment of visual acuity.
Measured: 12 Months
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Sep 2019
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targeted Therapy Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theodore Leng, MD, Principal investigator, Stanford Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120311
- Sponsor's protocol ID
- 3TDEX-02
- Status last verified
- Nov 2023
- First submitted
- 3 Oct 2019
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.
PubMed 36912792
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous
- ClinicalTrials.gov ID
- NCT04120311
- Acronym / sponsor ID
- 3TDEX-02
- Conditions
- Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy With Pit of Optic Disc, Commotio Retinae
- Keywords
- Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy with Pit of Optic Disc, Commotio Retinae, Vitritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Targeted Therapy Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 9 Oct 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 phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
Detailed description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I open label study | Experimental | Drug: Episcleral DexamethasoneDrug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone Other Names: • Sustained Release Transscleral Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years;
- Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
- Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF);
- Inflammatory disorders of the sclera, choroid, retina or vitreous
Key exclusion criteria (3 listed)
- Inability to understand informed consent, cooperate with testing or return to follow up visits;
- Pregnant or lactating women;
- Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
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 |
|---|---|---|
| Episcleral DexamethasoneAlso: Sequestered Transscleral, Controlled-Release Dexamethasone, Sustained Release Transscleral DexamethasoneSustained Release Episcleral Dexamethasone | Drug | Phase I open label study |
Primary outcome
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Time frame: 12 Months
Assessment of ocular safety as measured by comprehensive ophthalmic exam.
2 secondary outcomes
A secondary outcome is assessment of visual acuity.
Time frame: 12 Months
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 36912792Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
Related trials for Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
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.
Theodore Leng, MD principal investigator
Stanford Medicine
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 Episcleral Dexamethasone in people with Macular Edema and Radiation Retinopathy, run by Targeted Therapy Technologies, LLC 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 4 inclusion and 3 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 24 Nov 2023. 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?
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?
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. (time frame: 12 Months). 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 NCT04120311, which also lists 1 linked publication.
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 24 Nov 2023.