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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.
Several studies have revealed evidences on the substantial role of Vascular endothelial growth factor-A (VEGF-A) in enhancing neovascularization processes. Some studies have shown the efficacy of intravitreal Avastin in reducing level of VEGF-A to improve NVG. On the other hand, recent pathological studies demonstrated that neutralization of VEGF reduced vascularity and decreased scar formation during wound healing, showing that VEGF strongly influence scar tissue formation. This may reduce the formation of encapsulated cyst after glaucoma surgeries and thus might improve the surgical success rate. The effect of subconjunctival bevacizumab as an adjunctive therapy in filtering glaucoma surgeries has been recently illustrated.
We 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISA+AVI | Experimental | injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant |
|
| AVI | Active Comparator | Ahmed valve implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subconjunctival Avastin | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical failure | 12 months | |
| Change in intraocular pressure | day 1, week 1, and months 1, 3, 6, 9 |
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Inclusion Criteria:
Exclusion Criteria:
Only 1 eye per patient was included in this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nariman Nassiri, MD | Contact | (+98) 21 8877 4143 | drnassirin@sbmu.ac.ir |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanak Eye Surgery Center | Recruiting | Tehran | 1517973813 | Iran |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Ahmed Valve implant | Device | 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA) |
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