A Phase 2 interventional study of Ocriplasmin 25µg and Ocriplasmin 75µg in Vitrectomy, sponsored by ThromboGenics. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-17.
Sponsored by ThromboGenics · Phase 2, Interventional, and Treatment
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
ThromboGenics is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25µg of ocriplasmin intravitreal injection
Drug: Ocriplasmin 25µg
75µg of ocriplasmin intravitreal injection
Drug: Ocriplasmin 75µg
125µg of ocriplasmin intravitreal injection
Drug: Ocriplasmin 125µg
Intravitreal injection of placebo
Drug: Placebo
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
Also known as: Microplasmin
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
Also known as: Microplasmin
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
Also known as: Microplasmin
Intravitreal injection of placebo
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
Time frame: Day 7
The first patient was recruited on 29 Mar 2007 and the last patient completed the study on 02 Oct 2008.
| Milestone | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo |
|---|---|---|---|---|
| Started | 29 | 33 | 32 | 31 |
| Completed | 26 | 29 | 32 | 30 |
| Not completed | 3 | 4 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Death | 0 | 1 | 0 | 0 |
| Withdrew: Transport issue | 0 | 1 | 0 | 0 |
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
| percentage of participants | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo |
|---|---|---|---|---|
| Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | 13.8 | 18.2 | 31.3 | 10 |
Collected over Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocriplasmin 25µg | — | 2/29 (6.9%) | 29/29 (100%) |
| Ocriplasmin 75µg | — | 3/33 (9.1%) | 32/33 (97%) |
| Ocriplasmin 125µg | — | 0/32 (0%) | 31/32 (96.9%) |
| Placebo | — | 2/31 (6.5%) | 30/31 (96.8%) |
| Event | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo |
|---|---|---|---|---|
| DiverticulitisInfections and infestations | 1/29 | 0/33 | 0/32 | 0/31 |
| Anterior chamber inflammationEye disorders | 1/29 | 0/33 | 0/32 | 0/31 |
| PneumoniaInfections and infestations | 0/29 | 0/33 | 0/32 | 1/31 |
| SinutisInfections and infestations | 0/29 | 0/33 | 0/32 | 1/31 |
| Radius fractureMusculoskeletal and connective tissue disorders | 0/29 | 0/33 | 0/32 | 1/31 |
| Myocardial infarctionCardiac disorders | 0/29 | 1/33 | 0/32 | 0/31 |
| Bening pancreatic neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/29 | 1/33 | 0/32 | 0/31 |
| HypertensionVascular disorders | 0/29 | 1/33 | 0/32 | 0/31 |
| Event | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo |
|---|---|---|---|---|
| Conjunctival haemorrahgeEye disorders | 14/29 | 18/33 | 17/32 | 22/31 |
| Anterior chamber cellEye disorders | 12/29 | 13/33 | 13/32 | 7/31 |
| Anterior chamber flareEye disorders | 6/29 | 7/33 | 11/32 | 6/31 |
| Cataract nuclearEye disorders | 9/29 | 7/33 | 8/32 | 8/31 |
| Macular oedemaEye disorders | 5/29 | 10/33 | 4/32 | 7/31 |
| CataractEye disorders | 6/29 | 9/33 | 7/32 | 5/31 |
| Eye painEye disorders | 6/29 | 9/33 | 4/32 | 8/31 |
| Eyelid oedemaEye disorders | 7/29 | 3/33 | 3/32 | 7/31 |
| Retinal haemorrhageEye disorders | 7/29 | 6/33 | 5/32 | 7/31 |
| Retinal tearEye disorders | 2/29 | 7/33 | 4/32 | 1/31 |
| Age, Continuous(years) | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 66.9 ± 8.28 | 68.8 ± 9.07 | 66.9 ± 11.40 | 65.7 ± 11.60 | 66.1 ± 10.16 |
| Sex: Female, Male(Participants) | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 20 | 23 | 20 | 22 | 85 |
| Male | 9 | 10 | 12 | 9 | 40 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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ThromboGenics