Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

NCT02155049 | Completed Phase 3

• 2 other identifiers: TED-01Thyroid eye disease
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.

Conditions

Thyroid Associated Ophthalmopathies

Keywords

TED; Prostaglandin Analogues

Outcome Measures

Primary Outcomes (1)

• Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients.

  To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture.

  6 months

Secondary Outcomes (1)

• Number of participants with adverse events.

  9 months

Other Outcomes (1)

• Bimatoprost effect reversibility after treatment cessation.

  3 months

Study Arms (1)

Prostaglandin Analogues

EXPERIMENTAL

The patients will receive a single daily drop of bimatoprost for six months.

Drug: bimatoprost 0.03%

Interventions

bimatoprost 0.03% DRUG

The patients will receive a single daily drop of bimatoprost for six months.

Also known as: Lumigan (Allergan, Inc, Irvine, California)

Prostaglandin Analogues

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inactive TED (Clinical Activity Score below 3)
• Significant exophthalmos or orbital fat expansion.

You may not qualify if:

• Previous prostaglandin analogues treatment due to glaucoma
• Known prostaglandin analogues sensitivity.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Ophthalmology clinics, Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Maya Eiger, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 4, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

IL (1)