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

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ClinicalTrials.gov Identifier: NCT01429441
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : January 11, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vitreomacular Adhesion Including Macular Hole
Interventions Drug: Ocriplasmin
Other: Sham injection
Enrollment 220

Recruitment Details 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  
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg Subjects in the sham group received a single sham injection
Period Title: Overall Study
Started 146 74
Completed 108 51
Not Completed 38 23
Reason Not Completed
Adverse Event             5             1
Death             0             2
Lost to Follow-up             5             2
Physician Decision             1             0
Withdrawal by Subject             27             18
Arm/Group Title Ocriplasmin Sham Total
Hide Arm/Group Description Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg Subjects in the sham group received a single sham injection Total of all reporting groups
Overall Number of Baseline Participants 146 74 220
Hide Baseline Analysis Population Description
Safety Set: The Safety Set consists of all subjects who received treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 74 participants 220 participants
69.4  (9.99) 68.5  (10.94) 69.1  (10.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 74 participants 220 participants
Female
103
  70.5%
45
  60.8%
148
  67.3%
Male
43
  29.5%
29
  39.2%
72
  32.7%
1.Primary Outcome
Title Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28
Hide Description 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.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description:
Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Subjects in the sham group received a single sham injection
Overall Number of Participants Analyzed 145 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage (weighted across strata)
41.7
(33.7 to 49.8)
6.2
(0.9 to 11.6)
2.Secondary Outcome
Title Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
Hide Description ≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.
Time Frame Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description:
Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
Subjects in the sham group received a single sham injection
Overall Number of Participants Analyzed 144 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage (weighted across strata)
50.5
(42.4 to 58.5)
39.1
(28.3 to 49.9)
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).
Adverse Event Reporting 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.
 
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg Subjects in the sham group received a single sham injection
All-Cause Mortality
Ocriplasmin Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ocriplasmin Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/146 (33.56%)      27/74 (36.49%)    
Cardiac disorders     
Acute myocardial infarction * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Angina pectoris * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Atrial fibrillation * 1  1/146 (0.68%)  2 0/74 (0.00%)  0
Myocardial infarction * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Cardiac failure * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Cardiac failure congestive * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Ear and labyrinth disorders     
Vertigo * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Eye disorders     
Macular hole * 1  21/146 (14.38%)  21 9/74 (12.16%)  9
Retinal detachment * 1  3/146 (2.05%)  3 1/74 (1.35%)  1
Vitreous adhesions * 1  2/146 (1.37%)  2 2/74 (2.70%)  2
Blindness transient * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Iridocyclitis * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Night blindness * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Pupillary reflex impaired * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Retinal tear * 1  1/146 (0.68%)  1 2/74 (2.70%)  2
Retinal toxicity * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Retinal vasculitis * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Visual acuity reduced * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Gastrointestinal disorders     
Inguinal hernia * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Small intestinal obstruction * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Large intestinal stenosis * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
General disorders     
Non-cardiac chest pain * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Infections and infestations     
Cellulitis * 1  1/146 (0.68%)  1 1/74 (1.35%)  1
Diverticulitis * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Lobar pneumonia * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Localized infection * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Coccidioidomycosis * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Influenza * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Pneumonia * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Sepsis * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Urinary tract infection * 1  0/146 (0.00%)  0 1/74 (1.35%)  3
Injury, poisoning and procedural complications     
Burns third degree * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Hip fracture * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Abdominal wound dehiscence * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Anastomotic leak * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Humerus fracture * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Rib fracture * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Investigations     
Intraocular pressure increased * 1  3/146 (2.05%)  3 2/74 (2.70%)  4
Retinogram abnormal * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalemia * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Hypoglycemia * 1  1/146 (0.68%)  2 0/74 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Spinal osteoarthritis * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adrenal gland cancer * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Adrenocortical carcinoma * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Gastrointestinal stromal tumor * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Squamous cell carcinoma * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Bladder neoplasm * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Chronic myelomonocytic leukemia * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Endometrial cancer stage II * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Intraductal proliferative breast lesion * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Nervous system disorders     
Cerebrovascular accident * 1  3/146 (2.05%)  3 0/74 (0.00%)  0
Dizziness * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Transient ischemic attack * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Psychiatric disorders     
Anxiety * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Renal and urinary disorders     
Renal failure * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Hematuria * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Renal failure acute * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Reproductive system and breast disorders     
Ovarian cyst * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary edema * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Pulmonary embolism * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Chronic obstructive pulmonary disease * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
Surgical and medical procedures     
Adrenalectomy * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Hip surgery * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Vascular disorders     
Aortic stenosis * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Hypertension * 1  1/146 (0.68%)  1 0/74 (0.00%)  0
Femoral artery occlusion * 1  0/146 (0.00%)  0 1/74 (1.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocriplasmin Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   132/146 (90.41%)      57/74 (77.03%)    
Eye disorders     
Vitreous floaters * 1  57/146 (39.04%)  75 6/74 (8.11%)  6
Photopsia * 1  44/146 (30.14%)  53 6/74 (8.11%)  7
Vision blurred * 1  28/146 (19.18%)  34 4/74 (5.41%)  6
Cataract nuclear * 1  23/146 (15.75%)  30 10/74 (13.51%)  11
Cataract * 1  22/146 (15.07%)  26 10/74 (13.51%)  10
Macular fibrosis * 1  22/146 (15.07%)  26 8/74 (10.81%)  8
Visual acuity reduced * 1  22/146 (15.07%)  25 18/74 (24.32%)  26
Visual impairment * 1  21/146 (14.38%)  38 4/74 (5.41%)  6
Eye pain * 1  20/146 (13.70%)  22 6/74 (8.11%)  10
Photophobia * 1  19/146 (13.01%)  22 0/74 (0.00%)  0
Posterior capsule opacification * 1  17/146 (11.64%)  20 3/74 (4.05%)  4
Subretinal fluid * 1  17/146 (11.64%)  18 4/74 (5.41%)  4
Chromatopsia * 1  16/146 (10.96%)  18 2/74 (2.70%)  3
Conjunctival hemorrhage * 1  15/146 (10.27%)  17 2/74 (2.70%)  2
Metamorphopsia * 1  14/146 (9.59%)  15 5/74 (6.76%)  6
Retinal hemorrhage * 1  12/146 (8.22%)  12 4/74 (5.41%)  7
Retinal pigment epitheliopathy * 1  11/146 (7.53%)  12 3/74 (4.05%)  3
Macular hole * 1  9/146 (6.16%)  9 1/74 (1.35%)  1
Ocular discomfort * 1  9/146 (6.16%)  10 2/74 (2.70%)  2
Cystoid macular edema * 1  8/146 (5.48%)  10 2/74 (2.70%)  2
Lacrimation increased * 1  8/146 (5.48%)  10 2/74 (2.70%)  3
Foreign body sensation in eyes * 1  5/146 (3.42%)  5 6/74 (8.11%)  6
Retinal tear * 1  2/146 (1.37%)  2 4/74 (5.41%)  5
Cataract cortical * 1  1/146 (0.68%)  1 4/74 (5.41%)  4
Gastrointestinal disorders     
Nausea * 1  5/146 (3.42%)  6 6/74 (8.11%)  6
Infections and infestations     
Sinusitis * 1  8/146 (5.48%)  10 2/74 (2.70%)  2
Investigations     
Color vision tests abnormal * 1  43/146 (29.45%)  89 14/74 (18.92%)  18
Ophthalmological examination abnormal * 1  29/146 (19.86%)  44 15/74 (20.27%)  21
Intraocular pressure increased * 1  10/146 (6.85%)  10 9/74 (12.16%)  11
Visual acuity tests abnormal * 1  9/146 (6.16%)  10 2/74 (2.70%)  2
Nervous system disorders     
Headache * 1  9/146 (6.16%)  10 4/74 (5.41%)  4
Vascular disorders     
Hypertension * 1  10/146 (6.85%)  12 1/74 (1.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
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.
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
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01429441     History of Changes
Other Study ID Numbers: TG-MV-014
First Submitted: September 2, 2011
First Posted: September 7, 2011
Results First Submitted: October 29, 2015
Results First Posted: January 11, 2016
Last Update Posted: March 14, 2016