A Phase 4 interventional study of Low fluorescence Photodynamic therapy and core pars plana vitrectomy in Age-Related Macular Degeneration, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2012-09-27.
Sponsored by Johann Wolfgang Goethe University Hospital · Phase 4, Interventional, and Treatment
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 150 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
eyes with predominately classic lesions
Procedure: Low fluorescence Photodynamic therapy · Procedure: core pars plana vitrectomy · Drug: dexamethasone · Drug: bevacizumab
eyes with occult lesions
Drug: bevacizumab · Procedure: core pars plana vitrectomy · Drug: triamcincolone
42 J/cm2 for 72 sec
24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy
intravitreal injection of 0.8 mg dexamethasone
intravitreal injection of 1.25 mg bevacizumab
0.4 mL core pars plana vitrectomy
intravitreal injection of 8 mg triamcincolone
Best corrected visual acuity
Time frame: at the day of exam
Central macular thickness
Time frame: at the day of exam
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johann Wolfgang Goethe University Hospital