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Nonsteroidal Anti-inflammatory Drug

Episcleral Celecoxib for Macular Edema

Phase 1
Waitlist Available
Led By Theodore Leng, MD
Research Sponsored by Targeted Therapy Technologies, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Inflammatory disorders of the sclera, choroid, retina or vitreous
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test if a new drug is safe for people with macular edema and other inflammatory disorders of the retina. The drug's goal is to reduce inflammation.

Who is the study for?
This trial is for adults over 18 with inflammatory eye conditions like macular edema, affecting the retina or vitreous. Participants must have certain levels of visual impairment but not so severe that they can't see at all. Pregnant women, those who can't follow the study plan or have other serious eye issues besides inflammation are excluded.Check my eligibility
What is being tested?
The trial is testing Episcleral Celecoxib's safety and its ability to reduce swelling and prevent abnormal blood vessel growth in the eye. It's an early-stage (Phase I) study focusing on patients with various retinal diseases and swelling behind the eye.See study design
What are the potential side effects?
Since this is a Phase I trial primarily assessing safety, potential side effects aren't fully known yet. However, as Celecoxib is related to anti-inflammatory drugs, possible side effects may include local irritation or discomfort at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have inflammation in parts of my eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Secondary outcome measures
A is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
A is assessment of visual acuity.

Side effects data

From 2019 Phase 3 trial • 622 Patients • NCT03006276
4%
Dysgeusia
3%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
DFN-15 DB1
Placebo DB2
Placebo DB1
DFN-15 DB2
Overall

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I open label studyExperimental Treatment1 Intervention
Drug: Episcleral Celecoxib Other Names: Sequestered, Transscleral, Controlled-Release Celecoxib Sustained Release Transscleral Celecoxib

Find a Location

Who is running the clinical trial?

Targeted Therapy Technologies, LLCLead Sponsor
3 Previous Clinical Trials
45 Total Patients Enrolled
2 Trials studying Macular Edema
3 Patients Enrolled for Macular Edema
Theodore Leng, MDPrincipal InvestigatorStanford Medicine Ophthalmology [Recruiting]
2 Previous Clinical Trials
3 Total Patients Enrolled
2 Trials studying Macular Edema
3 Patients Enrolled for Macular Edema

Media Library

Episcleral Celecoxib (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04120636 — Phase 1
Macular Edema Clinical Trial 2023: Episcleral Celecoxib Highlights & Side Effects. Trial Name: NCT04120636 — Phase 1
Episcleral Celecoxib (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04120636 — Phase 1
Macular Edema Research Study Groups: Phase I open label study

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the food and drug administration given their approval to Episcleral Celecoxib?

"Our experts at Power have assessed that Episcleral Celecoxib holds a safety rating of 1, as the current Phase 1 trial has only presented scant evidence for its efficacy and security."

Answered by AI

What medical issues can be treated by Episcleral Celecoxib?

"Episcleral Celecoxib is a useful treatment for pain, primary dysmenorrhoea, and rheumatoid arthritis."

Answered by AI

How many participants are actively enrolled in this clinical investigation?

"Affirmative. Clinicaltrials.gov's listing states that this research endeavor, which was initially advertised on March 5th 2021, is actively looking for participants at the moment. Three individuals are needed from one medical centre involved in the trial."

Answered by AI

Are recruitment efforts underway for this clinical trial?

"According to clinicaltrials.gov, this research project is still recruiting and was first posted on March 5th 2021, with the last update taking place on May 11th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Stanford Medicine Ophthalmology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
2021. "Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04120636.
All > Macular Edema
~0 spots leftby Jun 2024
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