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Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials--TAP report. Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group.

Abstract

OBJECTIVE

To determine if photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) can safely reduce the risk of vision loss in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD).

DESIGN

Two multicenter, double-masked, placebo-controlled, randomized clinical trials.

SETTING

Twenty-two ophthalmology practices in Europe and North America.

PARTICIPANTS

Patients with subfoveal CNV lesions caused by AMD measuring 5400 microm or less in greatest linear dimension with evidence of classic CNV and best-corrected visual acuity of approximately 20/40 to 20/200.

METHODS

Six hundred nine patients were randomly assigned (2: 1) to verteporfin (6 mg per square meter of body surface area) or placebo (5% dextrose in water) administered via intravenous infusion of 30 mL over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm delivered 50J/cm2 at an intensity of 600 mW/cm2 over 83 seconds using a spot size with a diameter 1000 microm larger than the greatest linear dimension of the CNV lesion. At follow-up examinations every 3 months, retreatment with the same regimen was applied if angiography showed fuorescein leakage. The primary outcome was the proportion of eyes with fewer than 15 letters lost (approximately <3 lines of loss), adhering to an intent-to-treat analysis.

RESULTS

In each group, 94% of patients completed the month 12 examination. Visual acuity, contrast sensitivity, and fluorescein angiographic outcomes were better in the verteporfin-treated eyes than in the placebo-treated eyes at every follow-up examination through the month 12 examination. At the month-12 examination, 246 (61%) of 402 eyes assigned to verteporfin compared with 96 (46%) of 207 eyes assigned to placebo had lost fewer than 15 letters of visual acuity from baseline (P<.001). In subgroup analyses, the visual acuity benefit (< 15 letters lost) of verteporfin therapy was clearly demonstrated (67% vs 39%; P<.001) when the area of classic CNV occupied 50% or more of the area of the entire lesion (termed predominantly classic CNV lesions), especially when there was no occult CNV. No statistically significant differences in visual acuity were noted when the area of classic CNV was more than 0% but less than 50% of the area of the entire lesion. Few ocular or other systemic adverse events were associated with verteporfin treatment, compared with placebo, including transient visual disturbances (18% vs 12%), injection-site adverse events (13% vs 3%), transient photosensitivity reactions (3% vs 0%), and infusion-related low back pain (2% vs 0%).

CONCLUSIONS

Since verteporfin therapy of subfoveal CNV from AMD can safely reduce the risk of vision loss, we recommend verteporfin therapy for treatment of patients with predominantly classic CNV from AMD.

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    MeSH

    Aged
    Aged, 80 and over
    Choroidal Neovascularization
    Contrast Sensitivity
    Double-Blind Method
    Female
    Fluorescein Angiography
    Follow-Up Studies
    Fovea Centralis
    Fundus Oculi
    Humans
    Infusions, Intravenous
    Macular Degeneration
    Male
    Middle Aged
    Photochemotherapy
    Photosensitizing Agents
    Porphyrins
    Prospective Studies
    Safety
    Treatment Outcome
    Verteporfin
    Vision Disorders
    Visual Acuity

    Pub Type(s)

    Clinical Trial
    Clinical Trial, Phase III
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    10532441

    Citation

    "Photodynamic Therapy of Subfoveal Choroidal Neovascularization in Age-related Macular Degeneration With Verteporfin: One-year Results of 2 Randomized Clinical trials--TAP Report. Treatment of Age-related Macular Degeneration With Photodynamic Therapy (TAP) Study Group." Archives of Ophthalmology (Chicago, Ill. : 1960), vol. 117, no. 10, 1999, pp. 1329-45.
    Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials--TAP report. Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group. Arch Ophthalmol. 1999;117(10):1329-45.
    (1999). Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials--TAP report. Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group. Archives of Ophthalmology (Chicago, Ill. : 1960), 117(10), pp. 1329-45.
    Photodynamic Therapy of Subfoveal Choroidal Neovascularization in Age-related Macular Degeneration With Verteporfin: One-year Results of 2 Randomized Clinical trials--TAP Report. Treatment of Age-related Macular Degeneration With Photodynamic Therapy (TAP) Study Group. Arch Ophthalmol. 1999;117(10):1329-45. PubMed PMID: 10532441.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials--TAP report. Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group. PY - 1999/10/26/pubmed PY - 1999/10/26/medline PY - 1999/10/26/entrez SP - 1329 EP - 45 JF - Archives of ophthalmology (Chicago, Ill. : 1960) JO - Arch. Ophthalmol. VL - 117 IS - 10 N2 - OBJECTIVE: To determine if photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) can safely reduce the risk of vision loss in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD). DESIGN: Two multicenter, double-masked, placebo-controlled, randomized clinical trials. SETTING: Twenty-two ophthalmology practices in Europe and North America. PARTICIPANTS: Patients with subfoveal CNV lesions caused by AMD measuring 5400 microm or less in greatest linear dimension with evidence of classic CNV and best-corrected visual acuity of approximately 20/40 to 20/200. METHODS: Six hundred nine patients were randomly assigned (2: 1) to verteporfin (6 mg per square meter of body surface area) or placebo (5% dextrose in water) administered via intravenous infusion of 30 mL over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm delivered 50J/cm2 at an intensity of 600 mW/cm2 over 83 seconds using a spot size with a diameter 1000 microm larger than the greatest linear dimension of the CNV lesion. At follow-up examinations every 3 months, retreatment with the same regimen was applied if angiography showed fuorescein leakage. The primary outcome was the proportion of eyes with fewer than 15 letters lost (approximately <3 lines of loss), adhering to an intent-to-treat analysis. RESULTS: In each group, 94% of patients completed the month 12 examination. Visual acuity, contrast sensitivity, and fluorescein angiographic outcomes were better in the verteporfin-treated eyes than in the placebo-treated eyes at every follow-up examination through the month 12 examination. At the month-12 examination, 246 (61%) of 402 eyes assigned to verteporfin compared with 96 (46%) of 207 eyes assigned to placebo had lost fewer than 15 letters of visual acuity from baseline (P<.001). In subgroup analyses, the visual acuity benefit (< 15 letters lost) of verteporfin therapy was clearly demonstrated (67% vs 39%; P<.001) when the area of classic CNV occupied 50% or more of the area of the entire lesion (termed predominantly classic CNV lesions), especially when there was no occult CNV. No statistically significant differences in visual acuity were noted when the area of classic CNV was more than 0% but less than 50% of the area of the entire lesion. Few ocular or other systemic adverse events were associated with verteporfin treatment, compared with placebo, including transient visual disturbances (18% vs 12%), injection-site adverse events (13% vs 3%), transient photosensitivity reactions (3% vs 0%), and infusion-related low back pain (2% vs 0%). CONCLUSIONS: Since verteporfin therapy of subfoveal CNV from AMD can safely reduce the risk of vision loss, we recommend verteporfin therapy for treatment of patients with predominantly classic CNV from AMD. SN - 0003-9950 UR - https://www.unboundmedicine.com/medline/citation/10532441/full_citation L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/vol/117/pg/1329 DB - PRIME DP - Unbound Medicine ER -