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Enzyme

microplasmin, intravitreal injection for Age-Related Macular Degeneration (AMD Trial)

Phase 2
Waitlist Available
Led By Steven D Schwartz, M.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged 50 years or older
Presence of focal vitreomacular adhesion as seen by OCT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

AMD Trial Summary

The purpose of this study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)

Eligible Conditions
  • Age-Related Macular Degeneration

AMD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

AMD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The is the proportion of patients in whom there is release of vitreomacular traction as assessed by ultrasonography, optical coherence tomography and physical examination
Secondary outcome measures
Change in mean macular thickness
Incidence and severity of nonocular adverse events
Incidence and severity of ocular adverse events
+2 more

Side effects data

From 2016 Phase 4 trial • 108 Patients • NCT01429350
31%
Haemorrhage intracranial
26%
Urinary tract infection
19%
Hypokalaemia
18%
Atrial Fibrillation
15%
Dysphagia
15%
Constipation
15%
Brain oedema
13%
Hydrocephalus
13%
Headache
11%
Cerebrovascular accident
11%
Pyrexia
11%
Depression
11%
Nausea
8%
Leukocytosis
8%
Hypotension
8%
Insomnia
6%
Diarrhoea
6%
Acute Myocardial Infarction
6%
Pneumonia aspiration
6%
Hypertension
6%
Chest pain
6%
Anaemia
6%
Hyperglycaemia
6%
Bradycardia
5%
Gastrointestinal haemorrhage
5%
Pain in extremity
5%
Oral candiasis
5%
Renal failure acute
5%
Respiratory failure
5%
Vomiting
5%
Hypomagnesaemia
5%
Hyponatraemia
5%
Pulmonary embolism
5%
Deep vein thrombosis
3%
Hepatic enzyme increased
3%
Acute myocardial infarction
3%
Thrombocytopenia
3%
Intracranial pressure increased
3%
Atrial fibrillation
3%
Clostridium difficile colitis
3%
Fall
3%
Hypercholesterolaemia
3%
Hyperkalaemia
3%
Hypophosphataemia
3%
Electrolyte imbalance
3%
Hyperlipidaemia
3%
Hypernatraemia
3%
Hypocalcaemia
3%
Hypoglycaemia
3%
Convulsion
3%
Dizziness
3%
Mental status changes
3%
Renal failure
3%
Accelerated hypertension
3%
Orthostatic hypotension
3%
Leukopenia
3%
Haemorrhagic transformation stroke
3%
Pneumonia
3%
Hypoaesthesia
3%
Somnolence
3%
Hematemesis
2%
Oedema peripheral
2%
Complex regional pain syndrome
2%
Neck pain
2%
Haematuria traumatic
2%
Upper respiratory tract infection
2%
Sepsis
2%
Sinus tachycardia
2%
Ventricular fibrillation
2%
Hematesis
2%
Partial seizures
2%
Atrial septal defect
2%
Haemoglobin decreased
2%
Gout
2%
Lethargy
2%
Thrombophlebitis superficial
2%
Arrhythmia
2%
Cerebral haemorrhage
2%
Abdominal pain
2%
Cellulitis
2%
Oral infection
2%
Incision site complication
2%
Procedural nausea
2%
Vitamin D deficiency
2%
Acute respiratory failure
2%
Cough
2%
Dyspnoea
2%
Epistaxis
2%
Hyperventilation
2%
Hypoxia
2%
Nasal congestion
2%
Wheezing
2%
Ecchymosis
2%
Rash
2%
Gun shot wound
2%
Eye pain
2%
Oedema
2%
Laceration
2%
Anxiety disorder
2%
Benign prostatic hyperplasia
2%
Atrial flutter
2%
Thrombophlebitis
2%
Dementia Alzheimer's type
2%
Hypersensitivity
2%
Enterocolitis infectious
2%
Atrial thrombosis
2%
Palpitations
2%
Gastritis
2%
Gastrooesophageal reflux disease
2%
Gingival bleeding
2%
Peptic ulcer
2%
Vessel puncture site haemorrhage
2%
Dehydration
2%
Hypervolaemia
2%
Hypovolaemia
2%
Malnutrition
2%
Metabolic acidosis
2%
Muscle spasms
2%
Cerebral infarction
2%
Neuropathy peripheral
2%
Stroke in evolution
2%
Incontinence
2%
Pleural effusion
2%
Pulmonary congestion
2%
Pulmonary oedema
2%
Skin lesion
2%
Extrasystoles
2%
Haemorrhage
2%
Subdural haemorrhage
2%
Incision site hypoaesthesia
2%
Thrombocytosis
2%
Tachycardia
2%
Dry Eye
2%
Memory impairment
2%
Intraventricular haemorrhage
2%
Abdominal distension
2%
Wound
2%
Myalgia
2%
Cerebral artery occlusion
2%
Haemorrhagic cerebral infarction
2%
Loss of consciousness
2%
Anxiety
2%
Haematoma
2%
Electrocardiogram QT prolonged
2%
White blood cell count increased
2%
Pain
2%
Hyperchloraemia
2%
Impaired healing
2%
Vessel puncture site haematoma
2%
Antithrombin III decreased
2%
Blood magnesium decreased
2%
Mouth haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
IV rtPA
IV rtPA and IA Penumbra System

AMD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: microplasmin, intravitreal injectionExperimental Treatment1 Intervention
Subjects will receive one intravitreal injection of microplasmin on Day 0.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive one intravitreal injection of the placebo on Day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocriplasmin
FDA approved

Find a Location

Who is running the clinical trial?

ThromboGenicsIndustry Sponsor
30 Previous Clinical Trials
4,858 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,906 Total Patients Enrolled
Steven D Schwartz, M.D.Principal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025