Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration

Phase II study

Paul M. Beer, Barbara A. Blodi, David S. Boyer, Reagan H. Bradford, Sanford Chen, Joseph Googe, Lawrence S. Halperin, Patricia T. Harvey, Leonard Joffe, Jeffrey L. Marx, William F. Mieler, James F. Vander, Keye L. Wong, Seth L. Yoser

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

BACKGROUND: To determine short-term effects of topical diclofenac administered in conjunction with verteporfin therapy for predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS: Randomized, multicenter (14), prospective, placebo-controlled, double-masked clinical trial. Patients (n = 61) were randomly assigned to treatment with diclofenac sodium ophthalmic solution 0.1% or placebo and followed for 12 weeks. Patients instilled diclofenac or placebo two drops four times daily, 2-4 days before verteporfin treatment until 2 weeks after treatment, then two drops twice daily for 10 weeks. This exploratory study was not powered to detect differences between treatment groups. Statistical analyses were conducted solely to aid interpretation of results. RESULTS: In diclofenac-treated eyes, mean changes in visual acuity letter score from baseline in the diclofenac and placebo groups were +1.8 letters and -1.0 at week 1 (P = 0.505 between groups). Mean visual acuity letter scores decreased in both groups at all subsequent visits, with a mean change at 12 weeks of -7.4 with diclofenac and -2.6 with placebo (P = 0.213). Percentages of eyes with stable or improved vision (change ≤4 or increase ≥5 letters) were similar in the diclofenac and placebo groups at all study visits. No significant between-group differences in changes from baseline in lesion area, greatest linear dimension (GLD), fluorescein leakage, or retinal thickness were detected. CONCLUSION: In patients with predominantly classic subfoveal CNV due to AMD, administration of topical diclofenac with verteporfin therapy was associated with similar vision outcomes to placebo plus verteporfin therapy.

Original languageEnglish (US)
Pages (from-to)693-700
Number of pages8
JournalRetina
Volume27
Issue number6
DOIs
StatePublished - Jul 1 2007
Externally publishedYes

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Choroidal Neovascularization
Diclofenac
Macular Degeneration
Placebos
Therapeutics
Visual Acuity
Topical Administration
verteporfin
Ophthalmic Solutions
Fluorescein
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration : Phase II study. / Beer, Paul M.; Blodi, Barbara A.; Boyer, David S.; Bradford, Reagan H.; Chen, Sanford; Googe, Joseph; Halperin, Lawrence S.; Harvey, Patricia T.; Joffe, Leonard; Marx, Jeffrey L.; Mieler, William F.; Vander, James F.; Wong, Keye L.; Yoser, Seth L.

In: Retina, Vol. 27, No. 6, 01.07.2007, p. 693-700.

Research output: Contribution to journalArticle

Beer, PM, Blodi, BA, Boyer, DS, Bradford, RH, Chen, S, Googe, J, Halperin, LS, Harvey, PT, Joffe, L, Marx, JL, Mieler, WF, Vander, JF, Wong, KL & Yoser, SL 2007, 'Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration: Phase II study', Retina, vol. 27, no. 6, pp. 693-700. https://doi.org/10.1097/IAE.0b013e318030e519
Beer, Paul M. ; Blodi, Barbara A. ; Boyer, David S. ; Bradford, Reagan H. ; Chen, Sanford ; Googe, Joseph ; Halperin, Lawrence S. ; Harvey, Patricia T. ; Joffe, Leonard ; Marx, Jeffrey L. ; Mieler, William F. ; Vander, James F. ; Wong, Keye L. ; Yoser, Seth L. / Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration : Phase II study. In: Retina. 2007 ; Vol. 27, No. 6. pp. 693-700.
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abstract = "BACKGROUND: To determine short-term effects of topical diclofenac administered in conjunction with verteporfin therapy for predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS: Randomized, multicenter (14), prospective, placebo-controlled, double-masked clinical trial. Patients (n = 61) were randomly assigned to treatment with diclofenac sodium ophthalmic solution 0.1{\%} or placebo and followed for 12 weeks. Patients instilled diclofenac or placebo two drops four times daily, 2-4 days before verteporfin treatment until 2 weeks after treatment, then two drops twice daily for 10 weeks. This exploratory study was not powered to detect differences between treatment groups. Statistical analyses were conducted solely to aid interpretation of results. RESULTS: In diclofenac-treated eyes, mean changes in visual acuity letter score from baseline in the diclofenac and placebo groups were +1.8 letters and -1.0 at week 1 (P = 0.505 between groups). Mean visual acuity letter scores decreased in both groups at all subsequent visits, with a mean change at 12 weeks of -7.4 with diclofenac and -2.6 with placebo (P = 0.213). Percentages of eyes with stable or improved vision (change ≤4 or increase ≥5 letters) were similar in the diclofenac and placebo groups at all study visits. No significant between-group differences in changes from baseline in lesion area, greatest linear dimension (GLD), fluorescein leakage, or retinal thickness were detected. CONCLUSION: In patients with predominantly classic subfoveal CNV due to AMD, administration of topical diclofenac with verteporfin therapy was associated with similar vision outcomes to placebo plus verteporfin therapy.",
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T1 - Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration

T2 - Phase II study

AU - Beer, Paul M.

AU - Blodi, Barbara A.

AU - Boyer, David S.

AU - Bradford, Reagan H.

AU - Chen, Sanford

AU - Googe, Joseph

AU - Halperin, Lawrence S.

AU - Harvey, Patricia T.

AU - Joffe, Leonard

AU - Marx, Jeffrey L.

AU - Mieler, William F.

AU - Vander, James F.

AU - Wong, Keye L.

AU - Yoser, Seth L.

PY - 2007/7/1

Y1 - 2007/7/1

N2 - BACKGROUND: To determine short-term effects of topical diclofenac administered in conjunction with verteporfin therapy for predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS: Randomized, multicenter (14), prospective, placebo-controlled, double-masked clinical trial. Patients (n = 61) were randomly assigned to treatment with diclofenac sodium ophthalmic solution 0.1% or placebo and followed for 12 weeks. Patients instilled diclofenac or placebo two drops four times daily, 2-4 days before verteporfin treatment until 2 weeks after treatment, then two drops twice daily for 10 weeks. This exploratory study was not powered to detect differences between treatment groups. Statistical analyses were conducted solely to aid interpretation of results. RESULTS: In diclofenac-treated eyes, mean changes in visual acuity letter score from baseline in the diclofenac and placebo groups were +1.8 letters and -1.0 at week 1 (P = 0.505 between groups). Mean visual acuity letter scores decreased in both groups at all subsequent visits, with a mean change at 12 weeks of -7.4 with diclofenac and -2.6 with placebo (P = 0.213). Percentages of eyes with stable or improved vision (change ≤4 or increase ≥5 letters) were similar in the diclofenac and placebo groups at all study visits. No significant between-group differences in changes from baseline in lesion area, greatest linear dimension (GLD), fluorescein leakage, or retinal thickness were detected. CONCLUSION: In patients with predominantly classic subfoveal CNV due to AMD, administration of topical diclofenac with verteporfin therapy was associated with similar vision outcomes to placebo plus verteporfin therapy.

AB - BACKGROUND: To determine short-term effects of topical diclofenac administered in conjunction with verteporfin therapy for predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS: Randomized, multicenter (14), prospective, placebo-controlled, double-masked clinical trial. Patients (n = 61) were randomly assigned to treatment with diclofenac sodium ophthalmic solution 0.1% or placebo and followed for 12 weeks. Patients instilled diclofenac or placebo two drops four times daily, 2-4 days before verteporfin treatment until 2 weeks after treatment, then two drops twice daily for 10 weeks. This exploratory study was not powered to detect differences between treatment groups. Statistical analyses were conducted solely to aid interpretation of results. RESULTS: In diclofenac-treated eyes, mean changes in visual acuity letter score from baseline in the diclofenac and placebo groups were +1.8 letters and -1.0 at week 1 (P = 0.505 between groups). Mean visual acuity letter scores decreased in both groups at all subsequent visits, with a mean change at 12 weeks of -7.4 with diclofenac and -2.6 with placebo (P = 0.213). Percentages of eyes with stable or improved vision (change ≤4 or increase ≥5 letters) were similar in the diclofenac and placebo groups at all study visits. No significant between-group differences in changes from baseline in lesion area, greatest linear dimension (GLD), fluorescein leakage, or retinal thickness were detected. CONCLUSION: In patients with predominantly classic subfoveal CNV due to AMD, administration of topical diclofenac with verteporfin therapy was associated with similar vision outcomes to placebo plus verteporfin therapy.

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