Skip to main content
. 2017 Jun 22;2017(6):CD007419. doi: 10.1002/14651858.CD007419.pub5

Macugen 2011

Methods Parallel group RCT
One eye per person, unclear how eye selected
Participants Country: Australia, Europe, India, North America, and South America
Number of people randomised: 288 (288 eyes)
Average age: 62 years (20 to 83)
Sex: 43% women
Inclusion criteria:

  • 18 years or older

  • diabetes

  • DMO involving the centre of the macula not associated with ischaemia


(study eye)

  • foveal thickness of ≥ 250 µm (centre point thickness measured on OCT)

  • BCVA with a letter score of 65‐35 (20/50–20/200 Snellen equivalents)

  • IOP ≤ 21 mmHg

  • clear ocular media and adequate pupillary dilation to allow good quality stereoscopic fundus photography

  • focal or grid laser photocoagulation could be deferred for 18 weeks in the opinion of the treating ophthalmologist


Exclusion criteria:

  • yttrium‐aluminum‐garnet laser, peripheral retinal cryoablation, laser retinopexy for retinal tears, or focal or grid photocoagulation within the prior 16 weeks or scatter PRP 6 months before baseline or likely to be needed within 9 months

  • macular ischaemia if a nonperfusion area of > 1 disc area involving the foveal avascular zone (2 quadrants centred around the FAZ)
Interventions Intervention:

  • pegaptanib sodium (0.3 mg) n = 145 (145 eyes)


Comparator:

  • sham injection n = 143 (143 eyes)


Participants received pegaptanib 0.3 mg or sham injections every 6 weeks in year 1 (total 9 injections) and could receive focal/grid photocoagulation beginning at week 18. During year 2, participants received injections as often as every 6 weeks according to pre‐specified criteria
Outcomes Primary outcome:

  • 10‐letter (2‐line) improvement from baseline at 12 months (ETDRS chart)


Secondary outcomes: (at 12 and 24 months unless otherwise specified)

  • 10‐letter improvement from baseline at 24 months

  • changes from baseline in mean VA

  • 15‐letter (3‐line) improvement in VA

  • change in degree of retinopathy of 2 steps based on the 12‐step scale of retinopathy

  • decrease in retinal thickness at the centre point by 25% and 50%

  • focal or grid laser

  • change in NEI VFQ‐25 and EQ‐5D


Follow‐up: 12 and 24 months
Notes Dates participants enrolled: September 2005 to July 2009
Funding:"Sponsored by Pfizer Inc, New York, New York. The sponsor participated in the design of the study, in the management, analysis, and interpretation of the data, and in the preparation and review of the manuscript." Page 12
Conflict of interest: The authors were employees of Pfizer, the sponsor
Trial registration: NCT00605280
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "[...] subjects were centrally allocated to receive either pegaptanib 0.3 mg or sham injections (1:1) using a dynamic minimization procedure stratified by the site, hemoglobin A1c (<7.6% vs >=7.6%), systolic blood pressure (<140 vs >=140 mmHg), diastolic blood pressure (80 vs 80 mmHg), and baseline BCVA (<54 vs >=54 letters); the dynamic minimization used a stochastic treatment allocation algorithm based on the variance method." Page 3
Allocation concealment (selection bias) Low risk "...subjects were centrally allocated..." Page 3
Blinding of participants and personnel (performance bias) All outcomes Low risk "To maintain masking, the intravitreal procedure was identical between the sham and comparator arms, with the difference lying only in the application of an empty barrel of a needleless syringe in the sham procedure designed to mimic the intravitreal injection." Page 3
Blinding of outcome assessment (detection bias) All outcomes Low risk "Throughout the study, BCVA was measured at 4 m by the study refractionist/ophthalmologist, who was masked to the subject’s treatment and to the subject’s previous visual acuity (VA) assessments". Page 3
Incomplete outcome data (attrition bias) All outcomes Unclear risk At 1 year 116/144 (81%) pegaptanib‐treated participants and 114/142 (80%) controls completed the 54‐week visit. Adverse events led to discontinuation of 5 treated and 7 control participants
At 2 years 66 participants in each group completed the 102 week visit
ITT analysis with LOCF was used leading to the analysis of 133 treated and 127 control participants
Selective reporting (reporting bias) Low risk All primary outcomes reported
Other bias Low risk No other biases identified
Overall risk of bias Low risk Low risk of bias for most items