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Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

A

Asociación para Evitar la Ceguera en México

Status and phase

Terminated
Phase 2

Conditions

Age Related Macular Degeneration

Treatments

Procedure: verteporfin photodynamic therapy
Drug: bevacizumab intravitreal injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00347399
AvastinTFD

Details and patient eligibility

About

The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.

Full description

The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin

Enrollment

25 patients

Sex

All

Ages

55 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR)

Exclusion criteria

  • Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Dalma Jose Dalma-Weizhaus

Data sourced from clinicaltrials.gov

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