Steroid During Surgery vs Eye Drops After Surgery for Retinal Detachment

(DVS Trial)

Overseen by Nimesh A Patel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Corticosteroids

Disqualifiers: Glaucoma, Diabetic retinopathy, Infections, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if a steroid injection around the eye during surgery can replace the usual post-surgery eye drops for patients with a specific type of retinal detachment. The injection aims to reduce swelling and inflammation. Steroid injections around the eye have been used to control inflammation and pain after eye surgeries, offering prolonged drug activity at the target tissue.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those currently using oral, topical, or intravitreal corticosteroids. If you are on these medications, you may not be eligible to participate.

What data supports the effectiveness of the drug triamcinolone acetonide in the treatment of retinal detachment?

Research shows that triamcinolone acetonide, when used during eye surgery like pars plana vitrectomy, can reduce inflammation and speed up recovery, which may help improve surgical outcomes for retinal conditions. ^{1 2 3 4 5}

Is triamcinolone acetonide safe for use in eye surgeries?

Research shows that triamcinolone acetonide is generally safe for use during eye surgeries like pars plana vitrectomy, with studies evaluating its safety and effectiveness in reducing inflammation and visualizing the eye's interior. ^{1 3 4 5 6}

How is the drug Triamcinolone Acetonide used in retinal detachment surgery different from other treatments?

Triamcinolone Acetonide is unique in retinal detachment surgery because it can be used during the surgery itself, rather than as eye drops afterward, potentially reducing inflammation and speeding up recovery. It is injected directly into the eye, which may help improve surgical outcomes by providing immediate anti-inflammatory effects. ^{1 2 4 7 8}

Research Team

Nimesh A Patel, MD

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

This trial is for individuals with a primary type of retinal detachment who need surgery and can start treatment within seven days of diagnosis. It's not for those with prior eye surgeries (except laser), glaucoma, giant tears, or certain eye conditions like infections or inflammations.

Inclusion Criteria

I need surgery for a specific type of retinal detachment.

Exclusion Criteria

I have been diagnosed with an advanced stage of diabetic eye disease.

I am unable to make decisions for myself.

I cannot use or apply eye drops.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo pars plana vitrectomy with either subtenon triamcinolone acetonide or postoperative eye drops

1 day

1 visit (in-person)

Postoperative Treatment

Participants receive postoperative care including antibiotics and corticosteroids, with Group 1 receiving eye drops and Group 2 receiving subtenon injection

4 weeks

Multiple visits (in-person) for follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness, including assessments of visual acuity, intraocular pressure, and adverse events

12 weeks

Visits on Day 1, 7, 30, and 90 after surgery

Treatment Details

Interventions

• Atropine 1% (Drug)
• Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin (Drug)
• Pars plana vitrectomy (Procedure)
• Prednisolone 1% (Drug)
• Triamcinolone Acetonide 40mg/mL (Corticosteroid)

Trial Overview The study tests if using triamcinolone acetonide during surgery is as good as post-surgery eye drops in treating retinal detachment. Patients won't use post-op drops but will receive other standard medications and undergo pars plana vitrectomy.

Participant Groups

Group I: Group 2 Active Control 2 Interventions

* Subtenon triamcinolone acetonide (40 mg/1mLl) at the time of surgery * Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery * Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery * No postoperative eye drops

Group II: Group 1 Active Control 4 Interventions

* Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery * Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery * Topical moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; 4 times per day for 1 week after surgery. * Topical prednisolone 1% 1 drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) * Topical atropine 1% daily for 1 week

Pars plana vitrectomy is already approved in Canada for the following indications:

Approved in Canada as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

CarolAnn Williams

Massachusetts Eye and Ear Infirmary

Chief Executive Officer

MBA from Harvard Business School

Aalok Agarwala

Massachusetts Eye and Ear Infirmary

Chief Medical Officer since 2019

MD from University of California, Los Angeles

Findings from Research

In a study of 45 patients undergoing pars plana vitrectomy (PPV), the use of triamcinolone acetonide (TA) significantly reduced postoperative inflammation, as indicated by lower Tyndallometric mean values compared to a control group without TA.

Patients treated with TA showed improved recovery dynamics, with lower levels of blood-aqueous barrier disruption measured at 1 day, 10 days, and 6 weeks post-surgery, suggesting that TA administration enhances postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Decrease of the postoperative inflammatory reaction during pars plana vitrectomy (PPV) after administration of triamcinolone acetonide]. Mańkowska, A., Rejdak, R., Oleszczuk, A., et al.[2013]

In a study of 75 patients undergoing vitrectomy for idiopathic epiretinal membrane, the use of triamcinolone acetonide (TA) as an adjuvant therapy led to a significant reduction in central macular thickness compared to those who did not receive TA.

While both groups showed improvement in visual acuity after surgery, there was no significant difference in visual acuity change between the TA group and the control group, indicating that while TA may enhance anatomical outcomes, it does not necessarily translate to better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Concomitant Triamcinolone Acetonide Injection in Small-Gauge Vitrectomy for Idiopathic Epiretinal Membrane Peel. Sella, R., Gal-or, O., Goh, YW., et al.[2017]

Intraoperative use of triamcinolone acetonide (TA) during pars plana vitrectomy (PPV) significantly reduced the incidence of retinal breaks (8.7% vs. 14.1%) and retinal detachments (0.8% vs. 3.7%) compared to conventional PPV, based on a study of 774 patients across 8 hospitals.

While patients in the TA-assisted group required more antiglaucoma eye drops postoperatively, there were no serious adverse events related to TA use, indicating it is a safe option that enhances surgical outcomes without increasing major risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy. Yamakiri, K., Sakamoto, T., Noda, Y., et al.[2015]

Injected triamcinolone acetonide (TA) does not mix well with silicone oil and can form harmful crystals that may damage retinal cells, highlighting a potential safety concern in its use during surgery.

Creating a suspension of TA in silicone oil before injection allows for a stable, noncytotoxic release of TA over 90 days, suggesting a safer and more effective method for delivering this treatment in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The distribution, release kinetics, and biocompatibility of triamcinolone injected and dispersed in silicone oil. Spitzer, MS., Kaczmarek, RT., Yoeruek, E., et al.[2022]

In a phase III study involving 60 patients undergoing pars plana vitrectomy, preservative-free triamcinolone significantly improved visualization of posterior segment structures, with mean scores increasing from 0.5 to 3.7 after instillation (P < 0.0001).

Over 90% of surgeons reported that preservative-free triamcinolone enhanced visualization, and no safety issues were identified, indicating it is a safe and effective option for improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the safety and efficacy of preservative-free triamcinolone (triesence [triamcinolone acetonide injectable suspension] 40 mg/ml) for visualization during pars plana vitrectomy. Dyer, D., Callanan, D., Bochow, T., et al.[2015]

A single posterior subtenon injection of triamcinolone acetonide (TA) is as effective as a 4-week course of prednisolone acetate 1% eyedrops in reducing intraocular inflammation after pars plana vitrectomy (PPV), based on a study of 40 patients.

Both treatment methods showed similar safety profiles, with no significant differences in pain, inflammation, or side effects, and no cases of steroid-induced intraocular hypertension were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Paccola, L., Jorge, R., Barbosa, JC., et al.[2014]

In a pilot study of 24 patients with complex retinal detachment and extreme proliferative vitreoretinopathy, the application of Triamcinolone Acetonide (TA) crystal drops under silicone oil after surgery led to significantly better visual recovery compared to the control group without TA.

The use of TA crystals also resulted in fewer recurrences of retinal detachment and a higher rate of successful silicone oil removal, indicating improved anatomical outcomes and reduced complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete manuscript title: role of sub-silicone oil application of triamcinolone acetonide (TA) drops on outcomes after 360° relaxing retinectomy: a pilot study. Boral, SK., Agarwal, D., Das, A., et al.[2023]

In a case series of three patients undergoing TA-assisted vitrectomy for retinal detachment, subretinal deposition of triamcinolone acetonide (TA) was observed but resolved completely within three weeks without causing any adverse effects.

The successful attachment of the retina was confirmed two months post-surgery, suggesting that the presence of TA granules does not lead to functional damage, indicating that surgical removal of these deposits may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural history of sub-retinal triamcinolone acetonide deposition after triamcinolone-assisted vitrectomy. Sampangi, R., Venkatesh, P., Garg, SP.[2018]

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Decrease of the postoperative inflammatory reaction during pars plana vitrectomy (PPV) after administration of triamcinolone acetonide]. [2013]

2. China pubmed.ncbi.nlm.nih.gov

Role of Concomitant Triamcinolone Acetonide Injection in Small-Gauge Vitrectomy for Idiopathic Epiretinal Membrane Peel. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

The distribution, release kinetics, and biocompatibility of triamcinolone injected and dispersed in silicone oil. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the safety and efficacy of preservative-free triamcinolone (triesence [triamcinolone acetonide injectable suspension] 40 mg/ml) for visualization during pars plana vitrectomy. [2015]

6. Denmark pubmed.ncbi.nlm.nih.gov

Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Complete manuscript title: role of sub-silicone oil application of triamcinolone acetonide (TA) drops on outcomes after 360° relaxing retinectomy: a pilot study. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Natural history of sub-retinal triamcinolone acetonide deposition after triamcinolone-assisted vitrectomy. [2018]