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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02374060




Registration number
NCT02374060
Ethics application status
Date submitted
18/02/2015
Date registered
27/02/2015
Date last updated
4/12/2018

Titles & IDs
Public title
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Scientific title
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Secondary ID [1] 0 0
1U10EY024527-01
Secondary ID [2] 0 0
IRB00006139
Universal Trial Number (UTN)
Trial acronym
POINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Uveitis 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Periocular triamcinolone 40 mg
Treatment: Drugs - Intravitreal triamcinolone 4 mg
Treatment: Drugs - Dexamethasone intravitreal implant

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;

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;

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;


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Dexamethasone intravitreal implant
• Standard preparation as described for intravitreal injections.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
Timepoint [1] 0 0
At baseline and 8 weeks
Secondary outcome [1] 0 0
Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
Timepoint [1] 0 0
At baseline and the 24 week visit
Secondary outcome [2] 0 0
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
Timepoint [2] 0 0
Over 8 weeks of follow-up
Secondary outcome [3] 0 0
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
Timepoint [3] 0 0
Over 24 weeks of follow-up
Secondary outcome [4] 0 0
Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
Timepoint [4] 0 0
Over 8 weeks of follow-up
Secondary outcome [5] 0 0
Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
Timepoint [5] 0 0
Over 24 weeks of follow-up
Secondary outcome [6] 0 0
Change in Best-corrected Visual Acuity at 8 Weeks
Timepoint [6] 0 0
Over 8 weeks of follow-up
Secondary outcome [7] 0 0
Change in Best-corrected Visual Acuity at 24 Weeks
Timepoint [7] 0 0
Over 24 weeks of follow-up
Secondary outcome [8] 0 0
Number of Eyes With Vitreous Hemorrhage
Timepoint [8] 0 0
During 24 weeks of follow-up
Secondary outcome [9] 0 0
Number of Eyes With Retinal Tear or Detachment
Timepoint [9] 0 0
During 24 weeks of follow-up
Secondary outcome [10] 0 0
Number of Eyes With Endophthalmitis
Timepoint [10] 0 0
During 24 weeks of folllow-ip
Secondary outcome [11] 0 0
Cumulative Proportion of Eyes With Severe Vision Loss
Timepoint [11] 0 0
During 24 weeks of follow-up
Secondary outcome [12] 0 0
Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
Timepoint [12] 0 0
During 24 weeks of follow-up
Secondary outcome [13] 0 0
Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
Timepoint [13] 0 0
During 24 weeks of follow-up
Secondary outcome [14] 0 0
Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
Timepoint [14] 0 0
During 24 weeks of follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2018
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Victorian Eye & Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
JHSPH Center for Clinical Trials
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Eye Institute (NEI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas A Jabs, MD, MBA
Address 0 0
Icahn School of Medicine, Noutn Sinai, New York, NY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Thorne JE, Sugar EA, Holbrook JT, Burke AE, Altawe... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT02374060