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Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Vanak Eye Surgery Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanak Eye Surgery Center
ClinicalTrials.gov Identifier:
NCT01128699
First received: May 21, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 21, 2010
May 21, 2010
May 2010
May 2011   (final data collection date for primary outcome measure)
Change in intraocular pressure (IOP) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Same as current
No Changes Posted
  • Surgical failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Change in intraocular pressure [ Time Frame: day 1, week 1, and months 1, 3, 6, 9 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma
Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma: a Randomized Controlled Clinical Trial

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Refractory Glaucoma
  • Drug: Subconjunctival Avastin
    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)
  • Device: Ahmed Valve implant
    184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
  • Experimental: ISA+AVI
    injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant
    Intervention: Drug: Subconjunctival Avastin
  • Active Comparator: AVI
    Ahmed valve implant
    Intervention: Device: Ahmed Valve implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2011
May 2011   (final data collection date for primary outcome measure)

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.

Both
20 Years to 80 Years
Yes
Contact: Nariman Nassiri, MD (+98) 21 8877 4143 drnassirin@sbmu.ac.ir
Iran, Islamic Republic of
 
NCT01128699
VESC# 2010-142
Yes
Nader Nassiri, Associate Professor, Department of Ophthalmology, Imam Hossein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Vanak Eye Surgery Center
Not Provided
Not Provided
Vanak Eye Surgery Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP