What side effects are associated with this type of intervention?

Common treatments for macular edema include COX-2 inhibitors such as celecoxib. In clinical trials, celecoxib has been associated with a reduction in rectal polyps but also carries a risk of cardiovascular toxicity, especially in patients with a high baseline risk of cardiovascular events. Other side effects of systemic COX-2 inhibitors can include gastrointestinal issues and potential renal impairment. For ocular treatments, side effects may include dry eyes, conjunctivitis, and in rare cases, more severe conditions like macular edema or retinal detachment.

What prior FDA approvals exist?

The FDA has approved several treatments for macular edema, including COX-2 inhibitors. Celecoxib, a COX-2 selective NSAID, has shown promise in reducing inflammation and neovascularization in macular edema. Other COX-2 inhibitors like rofecoxib have also been studied for their efficacy in reducing retinal polyps and inflammation. These treatments aim to manage the inflammatory processes associated with macular edema, similar to the investigational use of Episcleral Celecoxib in ongoing trials.

What other types of research exist?

Promising novel alternatives to Episcleral Celecoxib for Macular Edema patients include anti-VEGF therapies such as Aflibercept and Ranibizumab, which have shown significant efficacy in reducing macular edema. Additionally, corticosteroid implants like Dexamethasone intravitreal implant (Ozurdex) and Fluocinolone acetonide implant (Iluvien) are also effective options. These treatments have been validated in multiple clinical trials and are widely used in clinical practice.

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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

Must not have

Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy

Inability to understand informed consent, cooperate with testing or return to follow up visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called Episcleral Celecoxib, which is applied to the outer layer of the eye. It is aimed at patients with macular edema and other inflammatory eye conditions. The drug works by reducing swelling and preventing harmful blood vessel growth in the eye. The main goal is to see if the treatment is safe and if it can improve vision by reducing 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.

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.

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

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I am 18 years old or older.

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I have inflammation in parts of my eye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have eye conditions that could affect safety or treatment results.

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I understand the consent form, can cooperate with tests, and can attend follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.

Secondary study objectives

A is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).

A is assessment of visual acuity.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Macular Edema is primarily caused by inflammation and increased vascular permeability, leading to fluid accumulation in the macula. COX-2 inhibitors like Celecoxib work by blocking the COX-2 enzyme, which plays a significant role in the inflammatory process, thereby reducing inflammation and fluid leakage. Corticosteroids also reduce inflammation by inhibiting multiple inflammatory pathways, while anti-VEGF agents target vascular endothelial growth factor to decrease abnormal blood vessel growth and permeability. These mechanisms are crucial for Macular Edema patients as they directly address the underlying causes of fluid accumulation, thereby improving vision and reducing the risk of long-term damage.