Trial · NCT02623426

Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

NCT02623426, Phase 3, Completed, JHSPH Center for Clinical Trials; results first posted 2023-07-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial. Trials, record NCT02623426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02623426

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial
NCT number: NCT02623426
Status: Completed
Phases: Phase 3
Enrollment: 194 participants, actual
Lead sponsor: JHSPH Center for Clinical Trials
Conditions: Uveitis, Macular Edema
Interventions: Dexamethasone intravitreal implant 0.7 mg, Intravitreal Methotrexate 400 µg, Intravitreal Ranibizumab 0.5 mg
First posted: 2015-12-07
Last updated: 2023-07-10
Results first posted: 2023-07-10

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks	At 12-week visit	The primary outcome is the change in central subfield thickness from baseline to 12 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. The proportion of baseline subfield thickness is estimated by a mixed effect model that includes time points for baseline, week 4, week 8, and week 12 and the treatment group. The treatment effect is the interaction (product) of time point and treatment. Contrasts of the model parameter estimates were used to calculate the change from baseline to week 12 and the comparison between treatment groups. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases (improvement).The OCT outcomes were measured by masked readers. The 12-week visit was chosen as the time to assess the primary outcome because of the ranibizumab treatment schedule and the peak effect time for dexamethasone

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks	At 12-week visit		Proportion of baseline retinal thickness	MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	0.65	95% Confidence Interval 0.58 to 0.72	Proportion of baseline retinal thickness
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	0.88	95% Confidence Interval 0.81 to 0.96	Proportion of baseline retinal thickness
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	0.79	95% Confidence Interval 0.70 to 0.89	Proportion of baseline retinal thickness

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	65	77
Overall Study	STARTED	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	65	79
Overall Study	STARTED	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	64	69
Overall Study	4 Week Visit	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	65	77
Overall Study	4 Week Visit	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	64	78
Overall Study	4 Week Visit	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	63	68
Overall Study	8 Week Visit	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	65	77
Overall Study	8 Week Visit	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	64	78
Overall Study	8 Week Visit	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	61	66
Overall Study	COMPLETED	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	64	76

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events75

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Eye pain	Eye disorders	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	5	65	7
other	Eye pain	Eye disorders	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	5	65	7
other	Eye pain	Eye disorders	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	4	64	5
other	Ocular hypertension	Eye disorders	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	3	65	3
other	Ocular hypertension	Eye disorders	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	2	65	2
other	Ocular hypertension	Eye disorders	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	1	64	1
other	Uveitis	Eye disorders	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	2	65	2
other	Uveitis	Eye disorders	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	2	65	2
other	Uveitis	Eye disorders	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	1	64	1
other	Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	1	65	1

1 to 10 of 75Source ClinicalTrials.gov

See all 75 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	0	65
Total, all-cause mortality	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	0	65
Total, all-cause mortality	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	0	64
Total, other adverse events	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	12	65
Total, other adverse events	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	24	65
Total, other adverse events	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	14	64
Total, serious adverse events	Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection	6	65
Total, serious adverse events	Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free	7	65
Total, serious adverse events	Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL	3	64

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37318415	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10EY024527	Macular Edema Treatment Trials Associated with MUST (META-MUST)	HOLBROOK, JANET T.	JOHNS HOPKINS UNIVERSITY	NATIONAL EYE INSTITUTE	2014 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02623426

GET https://conductscience.org/api/trials/v1/NCT02623426/events?page=2

API reference For AI assistants