Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma
1 other identifier
interventional
40
1 country
1
Brief Summary
The investigators aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMay 24, 2010
May 1, 2010
1 year
May 21, 2010
May 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in intraocular pressure (IOP)
To demonstrate the efficacy and safety of subconjuctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.
12 months
Secondary Outcomes (2)
Surgical failure
12 months
Change in intraocular pressure
day 1, week 1, and months 1, 3, 6, 9
Study Arms (2)
ISA+AVI
EXPERIMENTALinjection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant
AVI
ACTIVE COMPARATORAhmed valve implant
Interventions
Intraoperative Subconjunctival Avastin 1.25mg; single dose as an adjunct to 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of refractory glaucoma defined as uncontrolled IOP (\> 21 mm Hg) despite maximal antiglaucoma medication, previously failed surgical treatment, or a combination thereof
You may not qualify if:
- No light perception
- elevated IOP associated with silicone oil
- previous glaucoma drainage device implantation in the same eye
- previous cyclodestructive treatment
- increased risk of endophthalmitis (e.g., active adnexal and ocular surface infection, immunosuppression, or immunodeficiency, including the use of systemic steroids)
- posterior segment disorders, or pre-existing ocular comorbidities (e.g., pterygium, phacodonesis, corneal opacity, or corneal endothelial dystrophies).
- Only 1 eye per patient was included in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanak Eye Surgery Center
Tehran, 1517973813, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 24, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
July 1, 2011
Last Updated
May 24, 2010
Record last verified: 2010-05