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Trial record 1 of 2 for:    PeriOcular and INTravitreal corticosteroids for uveitic macular edema (POINT) Trial
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PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (POINT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by JHSPH Center for Clinical Trials
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier:
NCT02374060
First received: February 18, 2015
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Macular Edema
Uveitis
Drug: Periocular triamcinolone 40 mg
Drug: Intravitreal triamcinolone 4 mg
Drug: Dexamethasone intravitreal implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

Resource links provided by NLM:


Further study details as provided by JHSPH Center for Clinical Trials:

Primary Outcome Measures:
  • Percent change in central subfield thickness from the baseline OCT measurement [ Time Frame: At week 8 visit ]
    The primary outcome is the percent change in central subfield thickness from the baseline OCT measurement at the 8-week visit. The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. The results will be transformed to represent relative change. Assessment of OCT outcomes will be performed by masked readers.


Estimated Enrollment: 267
Study Start Date: March 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Periocular triamcinolone 40mg

Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0

Second injection permitted at Week 8 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;
  • IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Drug: Periocular triamcinolone 40 mg
Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.
Other Name: Kenalog
Active Comparator: Intravitreal triamcinolone 4mg

(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0

Second injection permitted at Week 8 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;
  • IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Drug: Intravitreal triamcinolone 4 mg
Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.
Other Name: Triescence (in U.S); Kenalog allowed at non-U.S. clinics
Active Comparator: Dexamethasoneintravitreal implant

Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0

Second injection permitted at Week 12 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;
  • IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Drug: Dexamethasone intravitreal implant
• Standard preparation as described for intravitreal injections.
Other Name: Ozurdex

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 criterion are met:

• IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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) 5/200 or better;
  • Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 3 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 infectious endophthalmitis in either eye;

History of central serous retinopathy 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(note that if patient is off of oral prednisone at baseline (P01 visit), dose stability requirement for past 4 weeks does not apply);
  • Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
  • 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;
  • Torn or ruptured posterior lens capsule;
  • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02374060

Contacts
Contact: Janet Holbrook, PhD, MPH jholbro1@jhu.edu
Contact: Jennifer E Thorne, MD, PhD

  Show 27 Study Locations
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Eye Institute (NEI)
Investigators
Study Chair: Douglas A Jabs, MD, MBA Icahn School of Medicine, Noutn Sinai, New York, NY
  More Information

Publications:
Nussenblatt R, Whitcup, SM, Palestine, AG. Uveitis: Fundamentals and Clinical Practice. 2 ed. St. Louis: Mosby; 1996.
Ozurdex (package insert). Allergan, Inc. Irvine, CA 92612: 2013.
Triesence (package insert). Alcon. Fort Worth, TX 76134: 2008.
LUCENTIS (ranibizumab injection) (Package Insert). Genentech Inc. South San Francisco, CA 94080: February 2013.
Diggle P HP, Liang K-Y, Zeger S. Analysis of Longitudinal Data. New York: Oxford University Press Inc.; 2002.
Gutierrez R. Parametric frailty and shared frailty survival models. The Stata Journal. 2002;2(1):22-44.
Daniels MJ HJ. Missing Data in Longitudinal Studies: Strategies for Bayesian Modeling and Sensitivity Analysis. Boca Raton: Chapman & Hall/CRC; 2008.
Little RJA RD. Statistical Analysis with Missing Data. 2nd ed. New York: John Wiley & Sons; 2002.

Responsible Party: JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier: NCT02374060     History of Changes
Other Study ID Numbers: IRB00006139
1U10EY024527-01 ( US NIH Grant/Contract Award Number )
Study First Received: February 18, 2015
Last Updated: September 13, 2016

Additional relevant MeSH terms:
Edema
Macular Edema
Macular Degeneration
Uveitis
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Dexamethasone acetate
Triamcinolone hexacetonide
Dexamethasone
Triamcinolone Acetonide
Triamcinolone
Dexamethasone 21-phosphate
BB 1101
Triamcinolone diacetate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2017