Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane

NCT02995746 | Terminated

• 1 other identifier: 15-475
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.

Conditions

Macular Edema; Epiretinal Membrane; Vitrectomy

Outcome Measures

Primary Outcomes (1)

• Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant

  Change in mean macular thickness baseline at 6 months

Secondary Outcomes (1)

• Visual acuity

  Change in visual acuity baseline at 6 months

Study Arms (1)

0.7mg dexamethasone intravitreal implant

EXPERIMENTAL

Single intravitreal implantation of 0.7mg dexamethasone with a six month follow up period

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

* On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant * Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant * Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan * Anticipated duration of the study: 6 months

Also known as: Ozurdex

0.7mg dexamethasone intravitreal implant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices
• Volunteer patients age 18 years and older
• Healthy enough to participate in the study
• Willing and able to consent to participation in the study
• History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months prior to study enrollment date
• BCVA of 20/40 or worse
• CMT of at least 400 micrometers with or without cystoid macular edema on SD-OCT
• Prior treatment with topical NSAIDs without resolution of macular thickening or visual acuity improvement

You may not qualify if:

• Advanced glaucoma (cup-disc ratio of 0.8 or greater)
• History of glaucoma filtering or tube shunt implant surgery
• Steroid responsive intraocular hypertension
• Diabetic retinopathy
• History of uveitis
• Use of systemic or intraocular corticosteroids
• Active or suspected ocular or periocular infections
• Other confounding intraocular pathology

Sponsors & Collaborators

• Wills Eye: lead
• Mid Atlantic Retina: collaborator

Study Sites (1)

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Macular Edema; Epiretinal Membrane

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Allen C Ho, MD

  Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: December 16, 2016
• Study Start: January 28, 2016
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)