Tissue plasminogen activator-assisted surgical excision of subfoveal choroidal neovascularization in age-related macular degeneration: a randomized, double-masked trial.
OBJECTIVE
To determine whether lysing subretinal fibrin with tissue plasminogen activator (t-PA) before excising subfoveal choroidal neovascularization improves visual acuity in patients with age-related macular degeneration.


METHODS
Randomized, double-masked trial.


METHODS
Eighty eyes of 80 patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration were studied.


METHODS
Each eye underwent pars plana vitrectomy and received a subretinal injection of t-PA or balanced salt solution (BSS) before the neovascular membrane was excised. Preoperative and postoperative protocol refraction, ophthalmic examination, color photography, and fluorescein angiography were performed in all 80 eyes.


METHODS
Visual acuity and fluorescein angiographic evidence of leakage after 1 year.


RESULTS
Visual acuity did not differ between the t-PA group (n = 40) and the BSS group (n = 40), and median best-corrected visual acuity was 20/320 for both groups (P = 0.38). Changes in visual acuity from baseline were also equal, with a median loss of 1 line in each group (P = 0.78). Patients whose initial visual acuity was 20/250 or less were more likely to improve by 2 or more lines (P = 0.01) and less likely to lose 2 or more lines (P < 0.001). Patients with choroidal neovascularization of at least 4 disc areas were more likely to improve by 2 or more lines (P = 0.02) and less likely to lose 2 or more lines (P < 0.001). After 1 year, choroidal neovascularization was present in seven of the t-PA eyes and in eight of the BSS eyes (P = 0.78).


CONCLUSIONS
With current surgical techniques, the use of t-PA before surgical excision of subfoveal choroidal neovascularization is of no visual or anatomic benefit to patients with age-related macular degeneration.
Lewis
H
H
Division of Ophthalmology, The Cleveland Clinic Foundation, Ohio, USA.
VanderBrug Medendorp
S
S
D000368:Aged; D002829:Choroid / Q000098:blood supply* / Q000187:drug effects / Q000601:surgery; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005584:Fovea Centralis; D005654:Fundus Oculi; D006801:Humans; D007267:Injections; D007552:Isotonic Solutions; D008268:Macular Degeneration / Q000150:complications*; D008297:Male; D009389:Neovascularization, Pathologic / Q000188:drug therapy / Q000209:etiology / Q000601:surgery*; D010960:Plasminogen Activators / Q000627:therapeutic use*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D014792:Visual Acuity; D014821:Vitrectomy
D007552:Isotonic Solutions; D010960:Plasminogen Activators; D010959:Tissue Plasminogen Activator