Retisert

Otitis Externa, Uveitis, Perianal erythema + 30 more

Treatment

3 FDA approvals

20 Active Studies for Retisert

What is Retisert

Fluocinolone acetonide

The Generic name of this drug

Treatment Summary

Fluocinolone acetonide is a type of corticosteroid that is used in dermatological treatments and to make implantable corticosteroid devices. These devices are made by Taro Pharmaceuticals and have been approved by the FDA since 2016. The formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide makes this drug highly lipophilic, or able to dissolve in fat.

Neo-Synalar

is the brand name

Retisert Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Neo-Synalar

Fluocinolone acetonide

1963

93

Approved as Treatment by the FDA

Fluocinolone acetonide, otherwise called Neo-Synalar, is approved by the FDA for 3 uses like Chronic Uveitis and Uveitis .

Chronic Uveitis

Uveitis

Uveitis

Effectiveness

How Retisert Affects Patients

Fluocinolone acetonide is a medication used to reduce inflammation. It comes in a form that can be injected directly into the eye, and has been shown to reduce the recurrence of uveitis flares by two times compared to patients not taking it. However, this medication can cause a slight increase in eye pressure, so it is important to monitor your pressure closely.

How Retisert works in the body

Fluocinolone acetonide is a steroid that reduces inflammation in the body. It works by binding to glucocorticoid receptors in the cell nucleus, which then triggers the production of proteins called lipocortins. These lipocortins stop the release of arachidonic acid, which is the precursor to inflammation-causing substances like prostaglandins and leukotrienes. This process reduces inflammation and prevents further damage.

When to interrupt dosage

The recommended dosage of Retisert is contingent upon the determined condition, including Hemorrhoids, Perianal erythema and Itch. The amount of dosage is contingent upon the method of administration (e.g. Kit or Emulsion - Topical) featured in the table below.

Condition

Dosage

Administration

Skin

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Conjunctivitis, Bacterial

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Pressure Ulcer

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Skin Inflammation caused by Bacterial Infections

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Uveitis

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Diabetic Macular Edema

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Postoperative Care

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Eczema

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Dermatitis, Seborrheic

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Otitis Externa

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Uveitis

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Otitis Media

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Chronic disease

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Surgery; Ear

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

postoperative treatment

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Ear structure

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Wound Infection

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Perianal erythema

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Scab

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Itching

, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg

, Topical, Cream, Cream - Topical, Ointment - Topical, Ointment, Solution, Solution - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Implant, Implant - Intravitreal, Shampoo, Shampoo - Topical, Intravitreal, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Emulsion - Topical, Emulsion, Intraocular, Implant - Intraocular, Gel

Warnings

Retisert has four prohibitions and should not be taken in combination with the ailments listed in the table below.

Retisert Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Fluocinolone Acetonide may interact with conjunctiva

Mycoses

Do Not Combine

External auditory canal structure

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Fluocinolone Acetonide may interact with conjunctiva

There are 20 known major drug interactions with Retisert.

Common Retisert Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Major

The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Abatacept.

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Fluocinolone acetonide.

Abetimus

Major

The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Abetimus.

Retisert Toxicity & Overdose Risk

Studies have not been conducted to determine the cancer-causing effects or the impact on fertility of taking fluocinolone acetonide. However, other corticosteroids have been shown to cause genetic damage, but tests have found that fluocinolone acetonide does not cause genetic damage.

Retisert Novel Uses: Which Conditions Have a Clinical Trial Featuring Retisert?

97 active clinical trials are currently being conducted to assess the utility of Retisert in alleviating Atopic Dermatitis, Otitis Media and Otitis Externa.

Condition

Clinical Trials

Trial Phases

Hemorrhoids

1 Actively Recruiting

Not Applicable

Perianal erythema

0 Actively Recruiting

Eczema

0 Actively Recruiting

Blister

0 Actively Recruiting

Otitis Externa

0 Actively Recruiting

Psoriasis of the scalp

1 Actively Recruiting

Phase 4

Otitis

3 Actively Recruiting

Not Applicable

Hemorrhoids

0 Actively Recruiting

Scab

0 Actively Recruiting

Ear structure

0 Actively Recruiting

Skin

0 Actively Recruiting

Skin Diseases

0 Actively Recruiting

Fissure in Ano

0 Actively Recruiting

Postoperative Care

5 Actively Recruiting

Early Phase 1, Phase 4, Not Applicable

Wound Infection

0 Actively Recruiting

Skin Inflammation caused by Bacterial Infections

0 Actively Recruiting

Uveitis

3 Actively Recruiting

Not Applicable, Phase 3

Conjunctivitis, Bacterial

0 Actively Recruiting

Coinfection

0 Actively Recruiting

Chronic disease

0 Actively Recruiting

Patient Q&A Section about retisert

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

How does RETISERT work?

"The Retisert implant is a corticosteroid used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The Retisert implant slowly releases the drug into the eye over a period of approximately 30 months. However, Retisert will not treat an eye infection."

Answered by AI

Who makes retisert?

"Two or more intraocular injections of 0.1 mL (8 mcg) of RETISERT [bimatoprost (r-prostaglandin F2 alpha)] were given 91 to 180 days apart in the study eye of 22 uveitis patients.

In a study of 22 uveitis patients, two or more intraocular injections of 0.1 mL (8 mcg) of RETISERT [bimatoprost (r-prostaglandin F2 alpha)] were given 91 to 180 days apart in the study eye."

Answered by AI

What is Yutiq?

"The YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is a medical device that is used to treat chronic non-infectious uveitis affecting the back of the eye."

Answered by AI

Clinical Trials for Retisert

Image of Mass Eye and Ear in Boston, United States.

Probiotic Supplementation for Diabetic Macular Edema

18+
All Sexes
Boston, MA

In this pilot prospective, interventional, longitudinal study, we aim to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME). The study seeks to address the following questions: 1. Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation? 2. Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation? 3. Is the number of anti-VEGF injections reduced following initiation of supplementation? Outcomes will be compared to a control group, using historic retrospective data. Participants will take Lactobacillus plantarum 299v orally twice daily for four months.

Phase 2
Waitlist Available

Mass Eye and Ear

Image of Johns Hopkins Bayview Medical Center in Baltimore, United States.

VR-Enhanced PMR for Post-Burn Symptoms

18+
All Sexes
Baltimore, MD

The goal of this clinical trial is to learn whether progressive muscle relaxation (PMR), delivered either alone or enhanced with virtual reality (VR), can help treat chronic symptom, such as pain, itch, anxiety, sleep disturbances, and fatigue, in adult burn survivors. The main questions it aims to answer are: * Does VR-enhanced PMR (VR-PMR) reduce chronic pain, anxiety, itch, sleep disturbances, and fatigue more effectively than standard PMR? * Is VR-PMR a feasible and acceptable self-administered home-based intervention for burn survivors? Researchers will compare two self-administered intervention conditions, VR-enhanced PMR and standard PMR, using a randomized to sequence crossover design to see if VR technology enhances the therapeutic effects of PMR on chronic symptom management in burn survivors. Participants will: * Complete home-based sessions of VR-enhanced PMR * Complete home-based sessions of standard PMR * Report symptoms such as pain, itch, anxiety, sleep disturbances, and fatigue throughout the study * Use VR equipment provided for the intervention period (during the VR-PMR arm)

Recruiting
Has No Placebo

Johns Hopkins Bayview Medical Center

Sheera Lerman Zohar, PhD

Have you considered Retisert clinical trials?

We made a collection of clinical trials featuring Retisert, we think they might fit your search criteria.
Go to Trials
Image of Dartmouth-Hitchcock Medical Center in Lebanon, United States.

Nutritional Shake for Postoperative Recovery

65+
All Sexes
Lebanon, NH

Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.

Recruiting
Has No Placebo

Dartmouth-Hitchcock Medical Center

Stacie G Deiner, MD

Have you considered Retisert clinical trials?

We made a collection of clinical trials featuring Retisert, we think they might fit your search criteria.
Go to Trials
Image of Associated Retinal Consultants PC in Phoenix, United States.

RO7446603 + Aflibercept/Faricimab for Diabetic Macular Edema

18+
All Sexes
Phoenix, AZ

This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.

Phase 1 & 2
Recruiting

Associated Retinal Consultants PC (+69 Sites)

Clinical Trials

Genentech, Inc.

Image of Retinal Consultants of AZ, Ltd in Peoria, United States.

RO7497372 for Diabetic Macular Edema

18+
All Sexes
Peoria, AZ

This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.

Phase 1
Waitlist Available

Retinal Consultants of AZ, Ltd (+36 Sites)

Clinical Trials

Genentech, Inc.

Image of St. Michael's Hospital in Toronto, Canada.

Rectal Methadone for Postoperative Pain

18 - 65
All Sexes
Toronto, Canada

Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery. The main questions are: 1. Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial? 2. Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better than the usual pain management. Participants will: * receive either Methadone or placebo during surgery. * be asked some questions about their pain during days 1 to 3 after surgery * be contacted by phone to ask about their recovery At this time, the study aims to recruit 40 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study.

Phase 4
Recruiting

St. Michael's Hospital

Sergio Pereira, MD PhD

Image of University of Virginia in Charlottesville, United States.

Methadone vs Remifentanil for Pain in Craniotomy Surgery

18 - 65
All Sexes
Charlottesville, VA

Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality. Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively. In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery. IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery. The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.

Phase < 1
Waitlist Available

University of Virginia

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