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PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

Information source: JHSPH Center for Clinical Trials
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Edema; Uveitis

Intervention: Periocular triamcinolone 40 mg (Drug); Intravitreal triamcinolone 4 mg (Drug); Dexamethasone intravitreal implant (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: JHSPH Center for Clinical Trials

Official(s) and/or principal investigator(s):
Douglas A Jabs, MD, MBA, Study Chair, Affiliation: Icahn School of Medicine, Noutn Sinai, New York, NY

Overall contact:
Janet Holbrook, PhD, MPH, Email: jholbro1@jhu.edu


To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects.

Clinical Details

Official title: PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percent change in central subfield thickness from the baseline OCT measurement

Detailed description: Macular edema is the most common structural complication and leading cause of visual loss in patients with uveitis. Regional injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e. g., triamcinolone acetonide, dexamethasone) and route of administration (e. g. periocular, intravitreal). The question of how to approach regional treatment of uveitic macular edema is a key question for ophthalmologists treating these patients. The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone (Kenalog® , Bristol-Myers Squibb Company, Princeton, NJ), intravitreal triamcinolone (Triesence™, Alcon Pharmaceuticals, Fort Worth, TX), and the intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine CA) will be conducted by the MUST Research Group clinical centers throughout the U. S. and one each in Australia and the UK. After signing informed consent and undergoing eligibility evaluation, eligible patients will be randomized to one of the three study treatments to be administered at the first study visit. Randomization is by participant, if both eyes meet eligibility requirements then both eyes receive assigned treatment. The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. After assessment of the primary outcome at 8 weeks, second injections and best medical judgment will be used if macular edema has not improved as follows: Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at P01 visit. Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if

- Eye does not meet the improvement definition (a 20% decrease in central subfield

thickness of the macula) or

- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central

subfield or

- ME is worse after initial improvement

And the following repeat injection criteria are met:

- IOP of ≤21 or mm Hg and treatment with ≤2 IOP-lowering agents;

- Best corrected visual acuity of 20/40 or worse;

Eyes demonstrating no improvement or worsening of ME as measured by the central submacular thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week 20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

Eye level inclusion criteria - at least one eye must meet all of the following conditions:

- Non-infectious anterior, intermediate, posterior or panuveitis; either active or

inactive uveitis is acceptable;

- Macular edema (ME) defined as the presence of central subfield macular thickness

greater than the normal range for the OCT machine being used, regardless of the presence of cysts, as assessed by study ophthalmologist;

- Best corrected visual acuity (BCVA) of 20/40 to 5/200;

- Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 2 or fewer

intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable);

- Baseline fluorescein angiogram that is gradable for leakage in the central subfield

- Pupillary dilation sufficient to allow OCT testing.

Exclusion Criteria: Patient level exclusion criteria:

- History of infectious uveitis, or of scleritis, keratitis, or endophthalmitis in

either eye;

- For women of childbearing potential: pregnancy, breastfeeding, or a positive

pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;

- Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;

- Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose

higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day that has not been stable for at least 4 weeks;

- Systemic immunosuppressive drug therapy that has not been stable for at least 4


- Known allergy or hypersensitivity to any component of the study drugs;

Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot

have any of the following conditions:

- History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥

0. 9 or any notching of optic nerve to the rim);

- Media opacity causing inability to assess fundus or perform OCT;

- Presence of an epiretinal membrane noted clinically or by OCT that per the judgment

of study ophthalmologist may be significant enough to limit improvement of ME (i. e., causing substantial wrinkling of the retinal surface)81;

- Presence of silicone oil;

- Periocular or intravitreal corticosteroid injection in past 8 weeks;

- Injection of dexamethasone intravitreal implant in past 12 weeks;

- Placement of fluocinolone acetonide implant (Retisert) in past 3 years;

- Topical NSAID use if dose has not been stable for at least 4 weeks.

Locations and Contacts

Janet Holbrook, PhD, MPH, Email: jholbro1@jhu.edu

Royal Victorian Eye & Ear Hospital, East Melbourne, Australia; Not yet recruiting
Cary Parfett, Phone: 61 3 9929 8076, Email: carly.parfett@unimelb.edu.au
Richard Stawell, Principal Investigator

United Kingdom Institute of Ophthalmology, London EC1V 9EL, United Kingdom; Not yet recruiting
Sophie Seguin-Greenstein, Phone: +44 0 79 5753 0377, Email: ssg@doctors.org.uk
Susan Lightman PhD, FRCOp FRCP, Principal Investigator

Jules Stein Eye Institute, UCLA, Los Angeles, California 90095, United States; Recruiting
Robert Almanzor, COA, Phone: 310-794-5602, Email: almanzor@jsei.ucla.edu
Gary Holland, MD, Principal Investigator

University of Southern California, Los Angeles, California 90033, United States; Recruiting
Margaret Padilla, Phone: 323-442-6490, Email: margaret.padilla@med.usc.edu
Narsing Rao, MD, Principal Investigator

University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
Salena Lee, OD, Phone: 415-476-4494, Email: salena.lee@ucsf.edu
Nisha Acharya, MD, Principal Investigator

Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine, Miami, Florida 33136, United States; Recruiting
Marie Chin, Phone: 305-326-6348, Email: mchin@med.miami.edu
Janet Davis, MD, Principal Investigator

University of South Florida, Tampa, Florida 33612, United States; Recruiting
JoAnn Leto, Phone: 813-974-7739, Email: jleto@health.usf.edu
Peter R Pavan, MD, Principal Investigator

Emory University, Atlanta, Georgia 30322, United States; Recruiting
Alcides Fernandes, MD, Phone: 404-778-2421, Email: afilho@emory.edu
Steven Yeh, MD, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Eileen Tonner, Phone: 312-563-4032, Email: eileen_e_tonner@rush.edu
Pauline Merrill, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Eileen L Tonner, Phone: 312-563-4032, Email: eileen_e_tonner@rush.edu
Pauline T Merrill, MD, Principal Investigator

University of Illinois at Chicago Eye Center, Chicago, Illinois 60612, United States; Recruiting
Julie Johnson, Phone: 312-503-2338, Email: j-johnson2@northwestern.edu
Debra A Goldstein, MD, Principal Investigator

Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Ahmadreza Moradi, MD, Phone: 410-502-6782, Email: amoradi1@jhmi.edu
Jennifer Thorne, MD, Principal Investigator

MUST Coordinating Center, Johns Hopkins University, Baltimore, Maryland 21231, United States; Recruiting
Nancy Prusakowski, MS, Phone: 410-955-8164, Email: nprusak1@jhu.edu
Janet T Holbrook, PhD, MPH, Principal Investigator

National Eye Institute, NIH, Bethesda, Maryland 20892, United States; Recruiting
Patti Sherry, RN, BSN, Phone: 301-435-4529, Email: sherryp@nei.nih.gov
Hatice N Sen, MD, Principal Investigator

Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan 48105, United States; Recruiting
Pamela Titus, Phone: 734-936-0138, Email: pamtitus@med.umich.edu
Susan G Elner, MD, Principal Investigator

Barnes Retina Institute, St. Louis, Missouri 63110, United States; Recruiting
Sam Pistorius, Phone: 314-747-5832, Email: PistoriusS@vision.wustl.edu
P Kumar Rao, MD, Principal Investigator

New York Eye and Ear Infirmary, New York, New York 10016, United States; Recruiting
Andrea Honda, Phone: 212-687-0265, Email: afhonda@gmail.com
Paul Latkany, MD, Principal Investigator

Duke Eye Center, Duke University, Durham, North Carolina 27710, United States; Recruiting
LaToya Greene, Email: latoya.greene@dm.duke.edu
Glenn J Jaffe, MD, Principal Investigator

Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Armin Farazdaghi, Phone: 215-662-8691, Email: Armin.Farazdaghi@uphs.upenn.edu
John H Kempen, MD, PhD, Principal Investigator

Vitreoretinal Consultants, Houston, Texas 77030, United States; Recruiting
Laura Shawver, Phone: 713-524-3434, Email: laura.shawver@houstonretina.com
Rosa Y Kim, MD, Principal Investigator

John A. Moran Eye Center, University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Kimberley Wegner, BS, CRC, Phone: 801-581-6265, Email: kimberley.wegner@hsc.utah.edu
Albert Vitale, MD, Principal Investigator

Additional Information

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