Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ThromboGenics

ClinicalTrials.gov Identifier:

NCT01429441

First received: September 2, 2011

Last updated: February 18, 2016

Last verified: January 2016

History of Changes

Results First Received: October 29, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Vitreomacular Adhesion Including Macular Hole
Interventions:	Drug: Ocriplasmin Other: Sham injection

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 25 study sites in the United States. The first subject was enrolled on 02 November 2011 and the last subject completed the study on 22 October 2014.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ocriplasmin	Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Sham	Subjects in the sham group received a single sham injection

Participant Flow: Overall Study

	Ocriplasmin	Sham
STARTED	146	74
COMPLETED	108	51
NOT COMPLETED	38	23
Adverse Event	5	1
Death	0	2
Lost to Follow-up	5	2
Physician Decision	1	0
Withdrawal by Subject	27	18

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Set: The Safety Set consists of all subjects who received treatment.

Reporting Groups

	Description
Ocriplasmin	Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Sham	Subjects in the sham group received a single sham injection
Total	Total of all reporting groups

Baseline Measures

	Ocriplasmin	Sham	Total
Overall Participants Analyzed [Units: Participants]	146	74	220

Age [Units: Years] Mean (Standard Deviation)	69.4 (9.99)	68.5 (10.94)	69.1 (10.30)

Gender [Units: Participants]
Female	103	45	148
Male	43	29	72

Outcome Measures

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1. Primary:

Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 [ Time Frame: Day 28 ]

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2. Secondary:

Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 [ Time Frame: Month 24 ]

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Serious Adverse Events

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Time Frame	Adverse events were collected from the injection day (Day 0) up to discontinuation from the study or completion of the study (Month 24).
Additional Description	The Safety Set consisted of all subjects who received study treatment and was used for all safety analyses. All subjects were included in the Safety Set: 146 subjects in the ocriplasmin group and 74 subjects in the sham group.

Reporting Groups

	Description
Ocriplasmin	Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Sham	Subjects in the sham group received a single sham injection

Serious Adverse Events

	Ocriplasmin	Sham
Total, Serious Adverse Events
# participants affected / at risk	49/146 (33.56%)	27/74 (36.49%)
Cardiac disorders
Acute myocardial infarction ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Angina pectoris ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Atrial fibrillation ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	2	0
Myocardial infarction ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Cardiac failure ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Cardiac failure congestive ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Ear and labyrinth disorders
Vertigo ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Eye disorders
Macular hole ^* 1
# participants affected / at risk	21/146 (14.38%)	9/74 (12.16%)
# events	21	9
Retinal detachment ^* 1
# participants affected / at risk	3/146 (2.05%)	1/74 (1.35%)
# events	3	1
Vitreous adhesions ^* 1
# participants affected / at risk	2/146 (1.37%)	2/74 (2.70%)
# events	2	2
Blindness transient ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Iridocyclitis ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Night blindness ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Pupillary reflex impaired ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Retinal tear ^* 1
# participants affected / at risk	1/146 (0.68%)	2/74 (2.70%)
# events	1	2
Retinal toxicity ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Retinal vasculitis ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Visual acuity reduced ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Gastrointestinal disorders
Inguinal hernia ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Small intestinal obstruction ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Large intestinal stenosis ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
General disorders
Non-cardiac chest pain ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Infections and infestations
Cellulitis ^* 1
# participants affected / at risk	1/146 (0.68%)	1/74 (1.35%)
# events	1	1
Diverticulitis ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Lobar pneumonia ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Localized infection ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Coccidioidomycosis ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Influenza ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Pneumonia ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Sepsis ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Urinary tract infection ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	3
Injury, poisoning and procedural complications
Burns third degree ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Hip fracture ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Abdominal wound dehiscence ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Anastomotic leak ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Humerus fracture ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Rib fracture ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Investigations
Intraocular pressure increased ^* 1
# participants affected / at risk	3/146 (2.05%)	2/74 (2.70%)
# events	3	4
Retinogram abnormal ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Metabolism and nutrition disorders
Hyperkalemia ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Hypoglycemia ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	2	0
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Spinal osteoarthritis ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Adrenocortical carcinoma ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Gastrointestinal stromal tumor ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Squamous cell carcinoma ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Bladder neoplasm ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Chronic myelomonocytic leukemia ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Endometrial cancer stage II ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Intraductal proliferative breast lesion ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Nervous system disorders
Cerebrovascular accident ^* 1
# participants affected / at risk	3/146 (2.05%)	0/74 (0.00%)
# events	3	0
Dizziness ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Transient ischemic attack ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Psychiatric disorders
Anxiety ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Renal and urinary disorders
Renal failure ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Hematuria ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Renal failure acute ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Reproductive system and breast disorders
Ovarian cyst ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Pulmonary embolism ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Chronic obstructive pulmonary disease ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1
Surgical and medical procedures
Adrenalectomy ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Hip surgery ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Vascular disorders
Aortic stenosis ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Hypertension ^* 1
# participants affected / at risk	1/146 (0.68%)	0/74 (0.00%)
# events	1	0
Femoral artery occlusion ^* 1
# participants affected / at risk	0/146 (0.00%)	1/74 (1.35%)
# events	0	1

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA version 17.1

Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor shall have the right to the 1st publication of the Study results (joint, multi-center publication in conjunction with PI). Following the 1st publication, PI may publish data/results from the Study; provided that PI submits the proposed publication to Sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may request that Confidential/Proprietary Information be deleted and/or publication be postponed to protect Sponsor's intellectual property rights.

Results Point of Contact:

Name/Title: Dr. Petra Kozma-Wiebe
Organization: ThromboGenics N.V.
phone: +32 16 751 497
e-mail: petra.kozma@thrombogenics.com

Responsible Party:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT01429441 History of Changes
Other Study ID Numbers:	TG-MV-014
Study First Received:	September 2, 2011
Results First Received:	October 29, 2015
Last Updated:	February 18, 2016

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