Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration.

Abstract

OBJECTIVE:

To evaluate the efficacy of a second year of pegaptanib sodium therapy in patients with neovascular age-related macular degeneration (AMD).

DESIGN:

Two concurrent, multicenter, randomized, double-masked, sham-controlled studies (V.I.S.I.O.N. [Vascular Endothelial Growth Factor Inhibition Study in Ocular Neovascularization] trials).

PARTICIPANTS:

Patients with all angiographic neovascular lesion compositions of AMD were enrolled. In combined analyses, 88% (1053/1190) were re-randomized at week 54, and 89% (941/1053) were assessed at week 102.

INTERVENTIONS:

At week 54, those initially assigned to pegaptanib were re-randomized (1:1) to continue or discontinue therapy for 48 more weeks (8 injections). Those initially assigned to sham were re-randomized to continue sham, discontinue sham, or receive 1 of 3 pegaptanib doses.

MAIN OUTCOME MEASURES:

Mean change in visual acuity (VA) over time and mean change in the standardized area under the curve of VA and proportions of patients experiencing a loss of > or =15 letters from week 54 to week 102; losing <15 letters (responders) from baseline to week 102; gaining > or =0, > or =1, > or =2, and > or =3 lines of VA; and progressing to legal blindness (20/200 or worse).

RESULTS:

In combined analysis, mean VA was maintained in patients continuing with 0.3-mg pegaptanib compared with those discontinuing therapy or receiving usual care. In patients who continued pegaptanib, the proportion who lost >15 letters from baseline in the period from week 54 to week 102 was half (7%) that of patients who discontinued pegaptanib or remained on usual care (14% for each). Kaplan-Meier analysis showed that patients continuing 0.3-mg pegaptanib for a second year were less likely to lose > or =15 letters than those re-randomized to discontinue after 1 year (P<0.05). The proportion of patients gaining vision was higher for those assigned to 2 years of 0.3-mg pegaptanib than receiving usual care. Progression to legal blindness was reduced for patients continuing 0.3-mg pegaptanib for 2 years.

CONCLUSIONS:

Continuing visual benefit was observed in patients who were randomized to receive therapy with pegaptanib in year 2 of the V.I.S.I.O.N. trials when compared with 2 years' usual care or cessation of therapy at year 1.

• Authors: VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group, U Chakravarthy, A P Adamis, E T Cunningham Jr, M Goldbaum, D R Guyer, B Katz, Manju Patel
• Journal: Ophthalmology (Ophthalmology) Vol. 113 Issue 9 Pg. 1508.e1-25 (Sep 2006) ISSN: 1549-4713 [Electronic] United States
• PMID: 16828500 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aptamers, Nucleotide
• VEGFA protein, human
• Vascular Endothelial Growth Factor A
• pegaptanib
• Indocyanine Green

Topics

• Aged
• Aged, 80 and over
• Aptamers, Nucleotide (adverse effects, therapeutic use)
• Choroidal Neovascularization (diagnosis, drug therapy, etiology)
• Double-Blind Method
• Female
• Fluorescein Angiography
• Humans
• Indocyanine Green
• Injections
• Macular Degeneration (complications, diagnosis, drug therapy)
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity
• Vitreous Body