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PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

NCT02374060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2018-12-04

Study results available
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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.

Conditions

  • Macular Edema
  • Uveitis

Interventions

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.

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.

DRUG

Dexamethasone intravitreal implant

• Standard preparation as described for intravitreal injections.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • JHSPH Center for Clinical Trials

    lead OTHER

Principal Investigators

  • Douglas A Jabs, MD, MBA · Icahn School of Medicine, Noutn Sinai, New York, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-16
Primary Completion
2017-08-30
Completion
2018-01-04

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374060 on ClinicalTrials.gov