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  • Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: Findings of the PERSPECTIVES study

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Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: Findings of the PERSPECTIVES study
  1. Usha Chakravarthy1,
  2. Giovanni Staurenghi2,
  3. Kenneth Kwok3,
  4. Charles S Tressler3,
  5. Ronald Buggage4,
  6. For The PERSPECTIVES Study Group*
  1. 1Central Angiographic Resource Facility, Queens University of Belfast, Belfast, UK
  2. 2Department of Clinical Science ‘Luigi Sacco’, Eye Clinic, University of Milan, Milano, Italy
  3. 3Pfizer Inc, New York, NY, USA
  4. 4Novagali Pharma, Evry, France
  5. *Listed in the on-line Appendix.
  1. Correspondence to Dr Usha Chakravarthy, Centre for Vision Sciences, Institute of Clinical Science, Royal Hospitals, Belfast BT12 6BA, Northern Ireland, UK; u.chakravarthy{at}qub.ac.uk

http://dx.doi.org/10.1136/bjophthalmol-2011-301444

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    Introduction

    Based on the success of intravitreal therapies targeting vascular endothelial growth factor,1–3 some of which suggested efficacy independent of lesion subtype,3 we investigated the benefit and safety of pegaptanib sodium in patients with early neovascular age-related macular degeneration (NV-AMD) versus those with established lesions.4

    Methods

    PERSPECTIVES (NCT00327470) was a 102-week, open-label trial. Participants aged ≥50 years with evidence of NV-AMD in at least one eye, clear ocular media and a visual acuity >25 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters, and a lesion <12 disc areas were eligible (see supplemental data, figure 1). Using an algorithm reflecting function and morphology, we characterised lesions as early when (a) the baseline visual acuity was ≥54 ETDRS letters and (b) on angiography with neovascularisation classified as occult with no classic or occult with classic consisting of <50% of lesion area, with no retinal haemorrhage, lipid exudation, or retinal pigment epithelial (RPE) detachment. Lesions were classified as established when classic neovascularisation comprised ≥50% of lesion area or if retinal haemorrhage, lipid exudation, or RPE detachment were present even if classic constituted <50% of lesion area.

    Figure 1

    Participant disposition. MITT, modified intent-to-treat. *Two participants withdrew …

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    Footnotes

    • ▸ Additional data are published online only. To view these files please visit the journal online (http://dx.doi.org/10.1136/bjophthalmol-2011-301444)

    • Contributors Contributed to study design, recruited participants, managed imaging centre, contributed to analysis, wrote paper and provided final approval. GS contributed to study design, recruited participants, managed imaging centre, contributed to analysis, wrote paper and provided final approval. KK study statistician, provided final approval. CT contributed to study design, data analysis and interpretation, provided input in writing paper and final approval. RB contributed to study design, data analysis and interpretation, provided input in writing paper and final approval.

    • Funding The research was supported by Pfizer Inc, New York, New York, USA. The study sponsor participated in the study design, analysis and interpretation of the data, the writing of the report and the decision to submit the paper for publication.

    • Competing interests Dr Chakravarthy has been an investigator in multiple Pfizer sponsored clinical trials and studies. She has also participated in Pfizer sponsored medical advisory boards. Mr Kwok and Dr Tressler are employees of Pfizer Inc. Dr Buggage was an employee of Pfizer Inc at the time the study was conducted.

    • Ethics approval Ethics Committees.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement A summary of the imaging data are available upon request to Pfizer Inc.