18 and older, any sex, with Macular Edema or Uveitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Baseline Central Subfield Thickness Observed at 8 WeeksPrimary· At baseline and 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.
Group
Value
95% CI
Periocular Triamcinolone 40mg
.77
.67 – .89
Intravitreal Triamcinolone 4mg
.61
.53 – .70
Dexamethasoneintravitreal Implant
.54
.46 – .63
Proportion of Baseline Central Subfield Thickness Observed at 24 WeeksSecondary· At baseline and the 24 week visit
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.
Group
Value
95% CI
Periocular Triamcinolone 40mg
0.68
0.59 – 0.79
Intravitreal Triamcinolone 4mg
0.64
0.56 – 0.74
Dexamethasoneintravitreal Implant
0.61
0.52 – 0.71
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 WeeksSecondary· Over 8 weeks of follow-up
Proportion of eyes with \>=20% reduction in macular thickness (or normalization of macular thickness even if there is \<20% reduction) at 8 weeks.
Group
Value
95% CI
Periocular Triamcinolone 40mg
0.41
0.29 – 0.52
Intravitreal Triamcinolone 4mg
0.79
0.70 – 0.88
Dexamethasoneintravitreal Implant
0.84
0.74 – 0.94
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 WeeksSecondary· Over 24 weeks of follow-up
Proportion of eyes with \>=20% reduction in macular thickness (or normalization of macular thickness even if there is \<20% reduction) at 24 weeks
Group
Value
95% CI
Periocular Triamcinolone 40mg
0.61
0.50 – 0.72
Intravitreal Triamcinolone 4mg
0.73
0.63 – 0.83
Dexamethasoneintravitreal Implant
0.74
0.61 – 0.85
Proportion of Eyes With Resolution of Macular Edema at 8 WeeksSecondary· Over 8 weeks of follow-up
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.
Group
Value
95% CI
Periocular Triamcinolone 40mg
0.20
0.12 – 0.30
Intravitreal Triamcinolone 4mg
0.47
0.34 – 0.60
Dexamethasoneintravitreal Implant
0.61
0.48 – 0.73
Proportion of Eyes With Resolution of Macular Edema at 24 WeeksSecondary· Over 24 weeks of follow-up
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.
Group
Value
95% CI
Periocular Triamcinolone 40mg
0.35
0.24 – 0.47
Intravitreal Triamcinolone 4mg
0.36
0.24 – 0.48
Dexamethasoneintravitreal Implant
0.41
0.28 – 0.54
Change in Best-corrected Visual Acuity at 8 WeeksSecondary· Over 8 weeks of follow-up
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.
Group
Value
95% CI
Periocular Triamcinolone 40mg
4.37
1.86 – 6.89
Intravitreal Triamcinolone 4mg
9.70
7.26 – 12.13
Dexamethasoneintravitreal Implant
9.53
7.01 – 12.05
Change in Best-corrected Visual Acuity at 24 WeeksSecondary· Over 24 weeks of follow-up
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.
Group
Value
95% CI
Periocular Triamcinolone 40mg
4.07
0.64 – 7.51
Intravitreal Triamcinolone 4mg
9.60
6.87 – 12.34
Dexamethasoneintravitreal Implant
9.21
6.62 – 11.80
Number of Eyes With Vitreous HemorrhageSecondary· During 24 weeks of follow-up
Count of eyes with vitreous hemorrhage as an immediate complication of injection.
Group
Value
95% CI
Periocular Triamcinolone 40mg
1
Intravitreal Triamcinolone 4mg
0
Dexamethasoneintravitreal Implant
1
Number of Eyes With Retinal Tear or DetachmentSecondary· During 24 weeks of follow-up
Count of eyes with retinal tears or detachments during the course of follow-up.
Group
Value
95% CI
Periocular Triamcinolone 40mg
1
Intravitreal Triamcinolone 4mg
0
Dexamethasoneintravitreal Implant
0
Number of Eyes With EndophthalmitisSecondary· During 24 weeks of folllow-ip
Count of eyes with an occurrence of endophthalmitis
Group
Value
95% CI
Periocular Triamcinolone 40mg
1
Intravitreal Triamcinolone 4mg
0
Dexamethasoneintravitreal Implant
0
Cumulative Proportion of Eyes With Severe Vision LossSecondary· During 24 weeks of follow-up
Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (\>= 15 standard letters) during the 24 weeks of follow-up.
Group
Value
95% CI
Periocular Triamcinolone 40mg
0.11
0.04 – 0.18
Intravitreal Triamcinolone 4mg
0.10
0.0 – 0.22
Dexamethasoneintravitreal Implant
0.05
0.0 – 0.10
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 weeks of follow-up.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06962839 — A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
· Phase 2
· recruiting
NCT06686641 — Incidence of Macular Edema in a Uveitis Population
· active not recruiting
NCT05976139 — Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
· NA
· recruiting
NCT05698329 — Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macula
· Phase 1
· active not recruiting
NCT06595355 — Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
· Phase 2, PHASE3
· recruiting
Other JHSPH Center for Clinical Trials trials
Trials by the same sponsor.
NCT06272045 — Early Intervention to Promote Cardiovascular Health of Mothers and Children
· NA
· recruiting
NCT06376994 — Multi-Center Clean Air Randomized Controlled Trial in COPD
· Phase 3
· recruiting
NCT04551807 — Natural Versus Programmed Frozen Embryo Transfer (NatPro)
· Phase 3
· active not recruiting
NCT03828019 — Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by JHSPH Center for Clinical Trials
Last refreshed: 4 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02374060.