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Combined Therapy in Age-Related Macular Degeneration (ARMD)

Combined Therapy in ARMD - Retrospective Case Series

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00805649
Enrollment
150
Registered
2008-12-09
Start date
2006-01-31
Completion date
2008-07-31
Last updated
2012-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Keywords

ARMD, combined therapy, efficacy, safety

Brief summary

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.

Detailed 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.

Interventions

PROCEDURELow fluorescence Photodynamic therapy

42 J/cm2 for 72 sec

PROCEDUREcore pars plana vitrectomy

24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy

DRUGdexamethasone

intravitreal injection of 0.8 mg dexamethasone

DRUGbevacizumab

intravitreal injection of 1.25 mg bevacizumab

DRUGtriamcincolone

intravitreal injection of 8 mg triamcincolone

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Wet age related macular degeneration

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuityat the day of exam
Central macular thicknessat the day of exam

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026