Trial · NCT01429441

Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

NCT01429441, Phase 3, Completed, ThromboGenics; results first posted 2016-01-11

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole. Trials, record NCT01429441. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01429441

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Trial

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

Title: Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
NCT number: NCT01429441
Status: Completed
Phases: Phase 3
Enrollment: 220 participants, actual
Lead sponsor: ThromboGenics
Conditions: Vitreomacular Adhesion Including Macular Hole
Interventions: Ocriplasmin, Sham injection
First posted: 2011-09-07
Last updated: 2016-03-14
Results first posted: 2016-01-11

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28	Day 28	Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.
Secondary	Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24	Month 24	≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28	Day 28	Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.	Percentage (weighted across strata)	NUMBER
SECONDARY	Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24	Month 24	FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.	Percentage (weighted across strata)	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28	Ocriplasmin	41.7	95% Confidence Interval 33.7 to 49.8	Percentage (weighted across strata)
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28	Sham	6.2	95% Confidence Interval 0.9 to 11.6	Percentage (weighted across strata)
Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24	Ocriplasmin	50.5	95% Confidence Interval 42.4 to 58.5	Percentage (weighted across strata)
Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24	Sham	39.1	95% Confidence Interval 28.3 to 49.9	Percentage (weighted across strata)

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ocriplasmin	146
Overall Study	STARTED	Sham	74
Overall Study	COMPLETED	Ocriplasmin	108
Overall Study	COMPLETED	Sham	51
Overall Study	NOT COMPLETED	Ocriplasmin	38
Overall Study	NOT COMPLETED	Sham	23

Source ClinicalTrials.gov

Adverse events198

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	Vitreous floaters	Eye disorders	Ocriplasmin	57	146	75
other	Vitreous floaters	Eye disorders	Sham	6	74	6
other	Photopsia	Eye disorders	Ocriplasmin	44	146	53
other	Photopsia	Eye disorders	Sham	6	74	7
other	Vision blurred	Eye disorders	Ocriplasmin	28	146	34
other	Vision blurred	Eye disorders	Sham	4	74	6
other	Cataract nuclear	Eye disorders	Ocriplasmin	23	146	30
other	Cataract nuclear	Eye disorders	Sham	10	74	11
other	Cataract	Eye disorders	Ocriplasmin	22	146	26
other	Cataract	Eye disorders	Sham	10	74	10

1 to 10 of 198Source ClinicalTrials.gov

See all 198 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ocriplasmin
Total, all-cause mortality	Sham
Total, other adverse events	Ocriplasmin	132	146
Total, other adverse events	Sham	57	74
Total, serious adverse events	Ocriplasmin	49	146
Total, serious adverse events	Sham	27	74

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30350717	DERIVED	PubMed
34250257	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Ocriplasmin vs Sham: serious adverse events

Source Trial comparisons

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.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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/NCT01429441

GET https://conductscience.org/api/trials/v1/NCT01429441/events?page=2

API reference For AI assistants