Macula EdemaPhase 1NCT04120636
Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
A Phase 1 study testing Episcleral Celecoxib in people with Macula 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 the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory 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
- Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion
- What is being tested?
- Episcleral Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 30 Jun 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 Celecoxib 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 the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.
Read the detailed description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema \& inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: 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).
- Conditions
- Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy With Pit of Optic Disc, Commotio Retinae
- Being tested
- Episcleral Celecoxib
- Keywords
- Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy with Pit of Optic Disc, Commotio Retinae, Vitritis
- Medical subject headings
- 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 CelecoxibDrug
Also called Sustained Release Transscleral Celecoxib
Sustained Release Transscleral Celecoxib
| Study group | Role | What they receive |
|---|---|---|
| Phase I open label study | Experimental | Drug: Episcleral Celecoxib
Other Names:
* Sequestered, Transscleral, Controlled-Release Celecoxib
* Sustained Release Transscleral Celecoxib Receives: Drug: Episcleral Celecoxib |
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 ocular safety assessment as measured by comprehensive ophthalmic exam.
The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Measured: 12 Months
Secondary outcomes (2)
A secondary outcome is assessment of visual acuity.
A 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 start5 Mar 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula 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
- 3 participants (estimated)
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 Ophthalmology [Recruiting]
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120636
- Sponsor's protocol ID
- 3TCEL-02
- Status last verified
- Nov 2023
- First submitted
- 4 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
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 Celecoxib 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
- NCT04120636
- Acronym / sponsor ID
- 3TCEL-02
- Conditions
- Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy With Pit of Optic Disc, Commotio Retinae
- Keywords
- Macula 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
- 3 participants (estimated)
- Lead sponsor
- Targeted Therapy Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 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 the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.
Detailed description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema \& inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: 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).
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 CelecoxibDrug: Episcleral Celecoxib Other Names: * Sequestered, Transscleral, Controlled-Release Celecoxib * Sustained Release Transscleral Celecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 CelecoxibAlso: Sustained Release Transscleral CelecoxibSustained Release Transscleral Celecoxib | Drug | Phase I open label study |
Primary outcome
The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Time frame: 12 Months
The primary outcome measure of the study is ocular safety assessment 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.
- Individual participant dataSharing planned: No
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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.
Theodore Leng, MD principal investigator
Stanford Medicine Ophthalmology [Recruiting]
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 Celecoxib in people with Macula 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 3 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?
The 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?
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.