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PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (POINT)

Primary Purpose

Macular Edema, Uveitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Periocular triamcinolone 40 mg
Intravitreal triamcinolone 4 mg
Dexamethasone intravitreal implant
Sponsored by
JHSPH Center for Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Jules Stein Eye Institute, UCLA
  • University of California, San Francisco
  • Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine
  • University of South Florida
  • Emory University
  • Northwestern University
  • Rush University Medical Center
  • University of Iowa
  • Johns Hopkins University
  • National Eye Institute, NIH
  • Massachusetts Eye and Ear Infirmary
  • Ophthalmic Consultants of Boston
  • Kellogg Eye Center, University of Michigan
  • MAYO Clinic
  • Washington University School of Medicine
  • New York Eye and Ear Infirmary
  • Duke Eye Center, Duke University
  • Scheie Eye Institute, University of Pennsylvania
  • Wills Eye Hospital
  • Unniversity of Pittsburgh Medical Center
  • Vitreoretinal Consultants
  • John A. Moran Eye Center, University of Utah
  • University of Washington
  • Royal Victorian Eye & Ear Hospital
  • McGill University
  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Periocular triamcinolone 40mg

Intravitreal triamcinolone 4mg

Dexamethasoneintravitreal implant

Arm Description

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;

(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;

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;

Outcomes

Primary Outcome Measures

Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. 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. Retinal thickness was evaluated using masked assessments of OCT images.

Secondary Outcome Measures

Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks.
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks
Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.
Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks.
Change in Best-corrected Visual Acuity at 8 Weeks
Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Change in Best-corrected Visual Acuity at 24 Weeks
Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Number of Eyes With Vitreous Hemorrhage
Count of eyes with vitreous hemorrhage as an immediate complication of injection.
Number of Eyes With Retinal Tear or Detachment
Count of eyes with retinal tears or detachments during the course of follow-up.
Number of Eyes With Endophthalmitis
Count of eyes with an occurrence of endophthalmitis
Cumulative Proportion of Eyes With Severe Vision Loss
Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up.
Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up.
Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up.
Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up.

Full Information

First Posted
February 18, 2015
Last Updated
November 6, 2018
Sponsor
JHSPH Center for Clinical Trials
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02374060
Brief Title
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Acronym
POINT
Official Title
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 16, 2015 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
January 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JHSPH Center for Clinical Trials
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192 subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned interim analysis and recommended that the goals of the trial could be accomplished by completing follow-up of enrolled subjects without the recruitment of additional subjects. Per the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was completed according to the protocol.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periocular triamcinolone 40mg
Arm Type
Active Comparator
Arm Description
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;
Arm Title
Intravitreal triamcinolone 4mg
Arm Type
Active Comparator
Arm Description
(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;
Arm Title
Dexamethasoneintravitreal implant
Arm Type
Active Comparator
Arm Description
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;
Intervention Type
Drug
Intervention Name(s)
Periocular triamcinolone 40 mg
Other Intervention Name(s)
Kenalog
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravitreal triamcinolone 4 mg
Other Intervention Name(s)
Triescence (in U.S); Kenalog allowed at non-U.S. clinics
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex
Intervention Description
• Standard preparation as described for intravitreal injections.
Primary Outcome Measure Information:
Title
Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
Description
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. 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. Retinal thickness was evaluated using masked assessments of OCT images.
Time Frame
At baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
Description
The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.
Time Frame
At baseline and the 24 week visit
Title
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
Description
Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks.
Time Frame
Over 8 weeks of follow-up
Title
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
Description
Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks
Time Frame
Over 24 weeks of follow-up
Title
Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
Description
Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.
Time Frame
Over 8 weeks of follow-up
Title
Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
Description
Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks.
Time Frame
Over 24 weeks of follow-up
Title
Change in Best-corrected Visual Acuity at 8 Weeks
Description
Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Time Frame
Over 8 weeks of follow-up
Title
Change in Best-corrected Visual Acuity at 24 Weeks
Description
Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Time Frame
Over 24 weeks of follow-up
Title
Number of Eyes With Vitreous Hemorrhage
Description
Count of eyes with vitreous hemorrhage as an immediate complication of injection.
Time Frame
During 24 weeks of follow-up
Title
Number of Eyes With Retinal Tear or Detachment
Description
Count of eyes with retinal tears or detachments during the course of follow-up.
Time Frame
During 24 weeks of follow-up
Title
Number of Eyes With Endophthalmitis
Description
Count of eyes with an occurrence of endophthalmitis
Time Frame
During 24 weeks of folllow-ip
Title
Cumulative Proportion of Eyes With Severe Vision Loss
Description
Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up.
Time Frame
During 24 weeks of follow-up
Title
Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
Description
Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up.
Time Frame
During 24 weeks of follow-up
Title
Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
Description
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up.
Time Frame
During 24 weeks of follow-up
Title
Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
Description
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up.
Time Frame
During 24 weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas A Jabs, MD, MBA
Organizational Affiliation
Icahn School of Medicine, Noutn Sinai, New York, NY
Official's Role
Study Chair
Facility Information:
Facility Name
Jules Stein Eye Institute, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
National Eye Institute, NIH
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Kellogg Eye Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
MAYO Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke Eye Center, Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Scheie Eye Institute, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Unniversity of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
John A. Moran Eye Center, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Victorian Eye & Ear Hospital
City
East Melbourne
Country
Australia
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3s5
Country
Canada
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 9EL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30269924
Citation
Thorne JE, Sugar EA, Holbrook JT, Burke AE, Altaweel MM, Vitale AT, Acharya NR, Kempen JH, Jabs DA; Multicenter Uveitis Steroid Treatment Trial Research Group. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial. Ophthalmology. 2019 Feb;126(2):283-295. doi: 10.1016/j.ophtha.2018.08.021. Epub 2018 Sep 27.
Results Reference
result

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PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

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