Iluvien

Otitis Externa, Uveitis, Perianal erythema + 30 more

Treatment

3 FDA approvals

20 Active Studies for Iluvien

What is Iluvien

Fluocinolone acetonide

The Generic name of this drug

Treatment Summary

Fluocinolone acetonide is a corticosteroid used in skin medications and implantable devices. It was first developed by Taro Pharmaceuticals and approved by the FDA in 2016. The drug has a high lipophilicity and has been studied extensively for its potential use in corticosteroid devices.

Neo-Synalar

is the brand name

Iluvien 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 Iluvien Affects Patients

Fluocinolone acetonide is a medication used to reduce inflammation. When used in the eyes, it is inserted as a tiny implant and has been found to reduce the recurrence of uveitis (inflammation of the eye) by two-fold compared to not taking any medication. However, it can cause an increase in the pressure inside the eye, so this should be monitored.

How Iluvien works in the body

Fluocinolone acetonide is a corticosteroid that helps reduce inflammation by binding to the glucocorticoid receptor and entering the cell nucleus. In the nucleus, it binds to genes that create a protein called lipocortin. This protein stops the production of other proteins that create inflammation, like prostaglandins, leukotrienes, and arachidonic acid. This allows fluocinolone to reduce inflammation in the body.

When to interrupt dosage

The measure of Iluvien is conditional upon the diagnosed condition, including Hemorrhoids, Perianal erythema and Itch. The measure of the dosage shifts, in line with the technique of delivery (e.g. Kit or Emulsion - Topical) featured in the table below.

Condition

Dosage

Administration

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Warnings

Iluvien has four contraindications and should not be taken when afflicted by any of the conditions listed in the following table.

Iluvien 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 Iluvien.

Common Iluvien 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.

Iluvien Toxicity & Overdose Risk

Studies have not yet been conducted to determine the effects of fluocinolone acetonide on fertility or cancer risk. However, while some corticosteroids have been found to be genotoxic, fluocinolone acetonide was determined to be non-genotoxic in an Ames test and a mouse lymphoma TK assay.

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

97 active studies are presently investigating the potential of Iluvien to ameliorate 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 iluvien

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

How much does ILUVIEN cost?

"The Iluvien intravitreal implant 0.19 mg costs approximately $9,276 for a single implant, depending on which pharmacy you visit."

Answered by AI

Is ILUVIEN an implant?

"ILUVIEN® is a 0.19 mg implant that is injected into the eye to treat diabetic macular edema in patients who have been treated with corticosteroids in the past and did not experience a significant increase in eye pressure."

Answered by AI

Who manufactures ILUVIEN?

"Some key points about Alimera: They gained distribution in the United States, they educated physicians on the benefits of Soothe, Alaway was approved by the FDA, and they sold both products to Bausch and Lomb."

Answered by AI

What is ILUVIEN used for?

"The implant is designed to help people with DME who have already tried other types of corticosteroids and have not had a significant increase in eye pressure."

Answered by AI

Clinical Trials for Iluvien

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

Image of University of California, Los Angeles in Los Angeles, United States.

Hemorrhoidal Artery Embolization for Hemorrhoids

18 - 90
All Sexes
Los Angeles, CA

Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.

Recruiting
Has No Placebo

University of California, Los Angeles

Lucas Cusumano, MD

Have you considered Iluvien clinical trials?

We made a collection of clinical trials featuring Iluvien, we think they might fit your search criteria.
Go to Trials
Image of Women and Infants Hospital in Providence, United States.

Postoperative Care for Minimally Invasive Gynecologic Surgery

18+
Female
Providence, RI

The goal of this randomized controlled trial is to assess recovery in patients undergoing benign laparoscopic gynecologic surgery. The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery? Researchers will compare postoperative recovery surveys from the control group (patients given standard postoperative restrictions limiting activity for 2 weeks) to the research group (patients given liberalized postoperative instructions allowing them to engage in their normal activities of daily life at their own discretion without prescribed activity restrictions) to see if liberalized postoperative restrictions improve the recovery experience. Participants will be asked to fill out a brief questionnaire at two time intervals, 1 week after surgery and 2 weeks after surgery.

Waitlist Available
Has No Placebo

Women and Infants Hospital

Christine Foley, MD

Image of The University of Alabama at Birmingham in Birmingham, United States.

Octreotide for Diabetic Macular Edema

18 - 90
All Sexes
Birmingham, AL

Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.

Phase 1
Waitlist Available

The University of Alabama at Birmingham

Maria Grant, MD, FARVO

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 (+70 Sites)

Clinical Trials

Genentech, Inc.

Have you considered Iluvien clinical trials?

We made a collection of clinical trials featuring Iluvien, we think they might fit your search criteria.
Go to Trials
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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