Refractory Diabetic Macular EdemaPhase 1NCT04005430
A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema
A Phase 1 study testing Episcleral Dexamethasone in people with Refractory Diabetic Macular Edema, 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 refractory diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Diabetic Macular Edema
- What is being tested?
- Episcleral Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 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
- Type I or II diabetes;
- 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 DME, within the central subfield (CSF);
- OCT CSF thickness value (microns):
- Zeiss Cirrus: ≥290 in women; ≥305 in men
Show all 9Show fewer
- Heidelberg Spectralis: ≥305 in women; ≥320 in men
- Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids;
- No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.
Who cannot join
- History of chronic renal failure requiring dialysis or kidney transplant;
- Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
- Evidence of external ocular infection;
- History of open-angle glaucoma or intraocular pressure >= 25 mmHg;
- History of steroid-induced IOP elevation that required IOP-lowering treatment;
- History of prior herpetic ocular infection;
Show all 16Show fewer
- History of intravitreal or periocular corticosteroids within 3 months prior to enrollment;
- History of macular laser photocoagulation within 4 months prior to enrollment;
- History of antiangiogenic therapy within 4 weeks prior to enrollment;
- History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment;
- Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments;
- No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study;
- Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment;
- Degenerative myopia;
- Malignant intraocular disease;
- 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: A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.
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 refractory diabetic macular edema. 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 reduce macular edema and improve vision in patients with diabetic macular edema.
- Conditions
- Refractory Diabetic Macular Edema
- Being tested
- Episcleral Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episcleral DexamethasoneDrug
Also called Sustained Release Transscleral Dexamethasone
Sequestered Transscleral, Controlled-Release Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Phase I open label study Receives: Drug: Episcleral Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of the study is safety assessment.
The main outcome of the study is safety assessment.
Measured: 12 Months
Secondary outcomes (2)
Secondary outcomes are assessment of visual acuity.
Secondary outcomes are assessment of visual acuity.
Measured: 12 Months
Secondary outcome are 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 posted2 Jul 2019
- Study start3 Apr 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.
- Other trials for Refractory Diabetic 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
- 1 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
- NCT04005430
- Sponsor's protocol ID
- 3TDEX01
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 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
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
- A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes
- ClinicalTrials.gov ID
- NCT04005430
- Acronym / sponsor ID
- 3TDEX01
- Conditions
- Refractory Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Targeted Therapy Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Jul 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 refractory diabetic macular edema.
Detailed description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema. 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 reduce macular edema and improve vision in patients with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: Episcleral DexamethasonePhase I open label study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type I or II diabetes;
- 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 DME, within the central subfield (CSF);
- OCT CSF thickness value (microns):
Key exclusion criteria (16 listed)
- History of chronic renal failure requiring dialysis or kidney transplant;
- Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
- Evidence of external ocular infection;
- History of open-angle glaucoma or intraocular pressure >= 25 mmHg;
- History of steroid-induced IOP elevation that required IOP-lowering treatment;
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: Sustained Release Transscleral DexamethasoneSequestered Transscleral, Controlled-Release Dexamethasone | Drug | Phase 1 |
Primary outcome
The primary outcome measure of the study is safety assessment.
Time frame: 12 Months
The main outcome of the study is safety assessment.
2 secondary outcomes
Secondary outcomes are assessment of visual acuity.
Time frame: 12 Months
Secondary outcome are 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.
- Individual participant dataSharing planned: No
Related trials for Refractory Diabetic Macular Edema
RecruitingObservational study
Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
Micropulse Laser, Treatment
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 Refractory Diabetic Macular Edema, 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 9 inclusion and 16 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?
The primary outcome measure of the study is safety assessment. (time frame: 12 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 24 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.