Triamcinolone Injections for Choroidal Effusions Post Glaucoma Surgery

(TRICEPS Trial)

Overseen By Cindy Rutz

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Choroidal hemorrhage, Aqueous misdirection, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of an anti-inflammatory injection, triamcinolone acetonide, for individuals experiencing eye swelling (choroidal effusions) after glaucoma surgery. Glaucoma surgery can sometimes cause excessive fluid drainage from the eye, resulting in swelling that may reduce vision. Participants will receive either the triamcinolone injection or a placebo to assess how quickly the swelling subsides. This study targets individuals who have undergone glaucoma surgery and continue to experience eye swelling after a week of standard treatment. As a Phase 4 trial, the research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, both groups in the study will continue to receive standard treatment with eye drops.

What is the safety track record for triamcinolone acetonide?

Research has shown that triamcinolone acetonide injections are generally safe and well-tolerated. In studies, only about 17% of patients experienced a rise in eye pressure after receiving the injection, indicating that most people did not have significant issues with eye pressure.

Triamcinolone acetonide is already used for other eye conditions, suggesting it is considered safe for ocular use. One study found that this treatment effectively reduced swelling at the back of the eye after glaucoma surgery without major problems.

Overall, the evidence supports triamcinolone acetonide as a safe option for treating certain eye conditions, including post-glaucoma surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for choroidal effusions after glaucoma surgery, which often involve observation or surgical interventions, the use of triamcinolone acetonide offers a unique approach. This treatment is exciting because it involves a steroid injection directly into the eye, targeting inflammation and potentially reducing effusions more rapidly and effectively than current methods. The precise delivery to the affected area allows for a concentrated anti-inflammatory effect, which could lead to faster recovery times and improved outcomes for patients. Researchers are particularly optimistic about the potential for triamcinolone to provide a less invasive, yet effective, alternative to more traditional surgical options.

What evidence suggests that triamcinolone injections could be effective for choroidal effusions post glaucoma surgery?

Research has shown that triamcinolone acetonide injections can help treat choroidal effusions, which are swellings at the back of the eye that can occur after glaucoma surgery. In this trial, some participants will receive triamcinolone acetonide injections, which have proven effective in resolving persistent or worsening swelling. Triamcinolone reduces inflammation and has been linked to better outcomes after glaucoma surgery. Specifically, it significantly increased the surgery's success rate compared to patients who did not receive the injection. This suggests that triamcinolone can reliably speed up healing and improve vision in affected patients. ^{2 3 4 5 6}

Who Is on the Research Team?

Catherine M Birt, MD FRCSC

Principal Investigator

Sunnybrook Research Institute

Are You a Good Fit for This Trial?

This trial is for patients over 18 who've had glaucoma surgery and developed persistent choroidal effusions at Sunnybrook Health Sciences Centre or Kensington Eye Institute. They must have seen no improvement after a week of standard treatment, be fluent in English, able to consent, and not pregnant or agree to use contraception.

Inclusion Criteria

Decision makers fluent in English

I am over 18 years old.

I had glaucoma surgery and my condition didn't improve after a week of standard treatment.

Exclusion Criteria

I am not pregnant and agree to use birth control during and for 40 days after treatment.

I have been diagnosed with bleeding in the back of my eye.

I have choroidal effusions but haven't had glaucoma surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a triamcinolone injection or a sham treatment, followed by topical prednisolone acetate 1% for 4 weeks

4 weeks

1 visit (in-person) for injection, followed by weekly monitoring

Follow-up

Participants are monitored for resolution of choroidal effusions, intraocular pressure, visual acuity, and any complications

3 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone Acetonide

Trial Overview The study tests if Triamcinolone injections can speed up the healing of choroidal effusions post-glaucoma surgery compared to a sham procedure. Both groups will continue with standard eye drop treatments while their recovery times are measured.

How Is the Trial Designed?

Group I: Injection Active Control 1 Intervention

Patients placed in a semi supine position. A cotton-tipped applicator saturated with proparacaine 0.5% (Alcaine, Alcon Labs) is placed into the conjunctival fornix of the supero-temporal quadrant for 5 minutes following initial proparacaine drops. After anaesthetic medication is placed, 1mL of a 40 mg/ml suspension of triamcinolone acetonide is injected through the superotemporal conjunctival fornix using a 25 Gauge needle, 5/8 inch length on a 3 ml syringe, following the contour of the globe with the needle, external to sclera for the full length of the needle such that the needle tip is ultimately positioned immediately posterior to the macula with the bevel down.

Group II: Control Placebo Group 1 Intervention

Patients placed in a semi supine position. A cotton-tipped applicator saturated with proparacaine 0.5% (Alcaine, Alcon Labs) is placed into the conjunctival fornix of the supero-temporal quadrant for 5 minutes following initial proparacaine drops. After anaesthetic medication is placed, a 3 ml syringe will be placed into the superotemporal conjunctival fornix but no needle is present and no drug injected.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/72601?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Triamcinolone Injections for Persistent Choroidal Effusio... The only effective treatment currently involves lowering the intraocular pressure (IOP) by medical, laser, or surgical techniques. Glaucoma ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35698758/

Subtenon triamcinolone injection to treat serous choroidal ... Subtenon injection of TA is a safe and effective modality of treatment for resolving a persistent or progressive SCD after glaucoma surgeries.

3. withpower.com withpower.com/trial/phase-4-glaucoma-9-2020-0aa73

Triamcinolone Injections for Choroidal Effusions Post ... This research is aimed at studying a new method of improving the outcomes of surgery for glaucoma patients, and further the treatment of glaucoma. Show more ...

4. e-century.us e-century.us/files/ijcem/12/6/ijcem0078805.pdf

Review Article The influence of triamcinolone acetonide on ... Over- all, compared with the control group for glaucoma surgery, triamcinolone acetonide can significantly improve the success rate (RR=1.27; 95 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40852329/

Intraocular Pressure Outcomes Following Suprachoroidal ... When removing eyes that had prior incisional glaucoma surgery, 17 (68%) of 25 eyes with prior steroid response still did not develop an IOP ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12367709/

Intraocular Pressure Outcomes Following Suprachoroidal ... Results: Ten (17%) of 59 eyes experienced an IOP increase of 5 mm Hg or greater following suprachoroidal triamcinolone acetonide injection. At ...