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Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Primary Purpose

Refractory Glaucoma

Status

Unknown status

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Subconjunctival Avastin

Ahmed Valve implant

About this trial

This is an interventional treatment trial for Refractory Glaucoma focused on measuring Ahmed valve, Neovascular Glaucoma, Uveitic glaucoma, Failed glaucoma, VEGF-A, Intraocular pressure, Subconjunctival Avastin

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of refractory glaucoma defined as uncontrolled IOP (> 21 mm Hg) despite maximal antiglaucoma medication, previously failed surgical treatment, or a combination thereof

Exclusion Criteria:

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.

Sites / Locations

Vanak Eye Surgery CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ISA+AVI

AVI

Arm Description

injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant

Ahmed valve implant

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical failure

Change in intraocular pressure

Full Information

NCT ID

NCT01128699

First Posted

May 21, 2010

Last Updated

May 21, 2010

Sponsor

Vanak Eye Surgery Center

1. Study Identification

Unique Protocol Identification Number

NCT01128699

Brief Title

Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Official Title

Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma: a Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2011 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Vanak Eye Surgery Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Glaucoma

Keywords

Ahmed valve, Neovascular Glaucoma, Uveitic glaucoma, Failed glaucoma, VEGF-A, Intraocular pressure, Subconjunctival Avastin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ISA+AVI

Arm Type

Experimental

Arm Description

injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant

Arm Title

AVI

Arm Type

Active Comparator

Arm Description

Ahmed valve implant

Intervention Type

Drug

Intervention Name(s)

Subconjunctival Avastin

Intervention Description

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)

Intervention Type

Device

Intervention Name(s)

Ahmed Valve implant

Intervention Description

184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

Primary Outcome Measure Information:

Title

Change in intraocular pressure (IOP)

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Surgical failure

Time Frame

12 months

Title

Change in intraocular pressure

Time Frame

day 1, week 1, and months 1, 3, 6, 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of refractory glaucoma defined as uncontrolled IOP (> 21 mm Hg) despite maximal antiglaucoma medication, previously failed surgical treatment, or a combination thereof Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nariman Nassiri, MD

Phone

(+98) 21 8877 4143

drnassirin@sbmu.ac.ir

Facility Information:

Facility Name

Vanak Eye Surgery Center

City

Tehran

ZIP/Postal Code

1517973813

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact: