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Combined Therapy in Age-Related Macular Degeneration (ARMD)

J

Johann Wolfgang Goethe University Hospital

Status and phase

Completed
Phase 4

Conditions

Age-Related Macular Degeneration

Treatments

Drug: dexamethasone
Procedure: core pars plana vitrectomy
Drug: bevacizumab
Drug: triamcincolone
Procedure: Low fluorescence Photodynamic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00805649
MK-KTAMD-2008

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD).

In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

Full description

This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.

Enrollment

150 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Wet age related macular degeneration

Exclusion criteria

  • Opacities in lens or cornea
  • Ongoing intraocular inflammation
  • Trauma

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 2 patient groups

1
Experimental group
Description:
eyes with predominately classic lesions
Treatment:
Procedure: Low fluorescence Photodynamic therapy
Procedure: core pars plana vitrectomy
Drug: dexamethasone
Drug: bevacizumab
Procedure: core pars plana vitrectomy
2
Experimental group
Description:
eyes with occult lesions
Treatment:
Drug: triamcincolone
Procedure: core pars plana vitrectomy
Drug: bevacizumab
Procedure: core pars plana vitrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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