MGD patients with lid margin telangiectasia meibomian gland dysfunction (MGD),
Conditions
Interventions
0.05% bevacizumab eye drop 4 times/ day,2.5% intra-
meibomian gland bevacizumab injection
Experimental Drug,Active Comparator Drug
Bevacizumab eye drop,Intra-
Sponsors
Ratchadapiseksompotch Fund
Ratchadapiseksompotch Fund
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Age 18-80 years • Symptoms ≥ 1: dryness, FB sensation, burning, tearing & duration > 6 months • Diagnosis of MGD stage 2 or 3 with lid margin telangiectasia grade 2 or 3 both eyes • Willingness to regular follow-up as appointed
Exclusion criteria
Exclusion criteria: • Ocular structure abnormality • History of ocular trauma, ocular and other surgery • Use of any treatment for DED or MGD except artificial tears within the past month • Active allergy, infection, inflammation at ocular surface unrelated to DE, MGD • History of ocular herpes infection • Lacrimal gland drainage system abnormality • Contact Lens wear within the past month • Use systemic medication affecting the ocular surface,systemic anti-inflammatory medication, anticoagulant or antiplatelet medication • Unstable systemic diseases: uncontrolled HT, uncontrolled DM, stroke, coronary artery disease, cerebrovascular disease, bleeding diathesis • History of bevacizumab contra-indication: congestive heart failure, GI perforation, pregnancy, breast feeding, reversible posterior leukoencephalopathy syndrome (RPLS), proteinuria, surgery and wound healing complications • Allergy to bevacizumab, moxifloxacin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of lid margin redness Baseline, 1, 4, 8, 12 weeks Area of redness devided by region of interest | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective lid margin telangiectasia Baseline, 1, 4, 8, 12 weeks Grading 0-3,Meibomian gland expression score Baseline, 1, 4, 8, 12 weeks Grading 0-45,Ocular Surface Disease Index (OSDI) Baseline, 1, 4, 8, 12 weeks 0-100,Tear break up time (TBUT) Baseline, 1, 4, 8, 12 weeks 0-10,Non-invasive TBUT Baseline, 1, 4, 8, 12 weeks 0-10,Corneal staining Baseline, 1, 4, 8, 12 weeks Oxford grading 0-5,Conjunctival redness Baseline, 1, 4, 8, 12 weeks 0-4,Meibography score Baseline, 1, 4, 8, 12 weeks 0-6,Lipid layer thickness Baseline, 1, 4, 8, 12 weeks ICU,Lid hygiene compliance Baseline, 1, 4, 8, 12 weeks 7 times/week,Bevacizumab eye drop compliance Baseline, 1, 4, 8, 12 weeks No./ day,Non-Invasive Tear Break Up Time (NI-TBUT) Baseline, 1, 4, 8, 12 weeks 0-10,Tear substitutes compliance Baseline, 1, 4, 8, 12 weeks No./ day,Local adverse event Baseline, 1, 4, 8, 12 weeks No. Of event,Systemic adverse event Baseline, 1, 4, 8, 12 weeks No. Of event | — |
Countries
Thailand
Contacts
Public ContactKrit Pongpirul
Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed