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. 2016 Dec 15;2016(12):CD011160. doi: 10.1002/14651858.CD011160.pub2

Parodi 2010.

Methods Study design: parallel group randomised controlled trial.
Unit of randomisation and analysis: the participant (one study eye per participant). The criteria for eye selection were not reported.
Participants Country: Italy
Setting: Department of Ophthalmology at the University of Udine and University of Trieste
Number of participants: 54
Number of men: 17
Number of women: 37
Age (mean): 50.8 years in the bevacizumab group, 48.1 years in the PDT group and 44.5 years in the laser treatment group
Ethnic group: not reported
Inclusion criteria:
  • CNV secondary to pathological myopia (refractive error ≥ ‐6.0 D). If refractive error < ‐6.0 D, the eye was eligible if it had retinal abnormalities consistent with pathological myopia and the axial length of the eye was at least 26.5 mm);

  • classic, well‐defined juxtafoveal CNV (1 to 200 μm from the foveal centre) shown on FA;

  • greatest linear dimension no larger than 5400 μm;

  • BCVA from 20/200 to 20/40 on an ETDRS chart;

  • duration of symptoms < 1 month;

  • documented VA deterioration within the last month.


Exclusion criteria:
  • evidence of any condition other than pathological myopia associated with CNV;

  • any significant ocular disease that had compromised or could compromise vision in the study eye;

  • active hepatitis;

  • clinically significant liver disease, porphyria or other porphyrin sensitivity; or pregnancy;

  • peripheral vascular disease, thromboembolism or stroke;

  • intraocular surgery within the last 2 months or capsulotomy in the study eye within the last month;

  • previous laser photocoagulation.

Interventions Intervention: intravitreal bevacizumab 1.25 mg, retreatment afterwards based on OCT or FA changes (19 participants)
Comparator 1: PDT with verteporfin (following the Verteporfin in Photodynamic Therapy Study Group guidelines) (18 participants)
Comparator 2: krypton laser photocoagulation, eyes developed recurrent CNV with subfoveal location during follow‐up could be retreated using PDT (17 participants)
Outcomes Primary outcome:
  • mean change in BCVA compared with baseline.


Secondary outcomes:
  • proportion of participants who gained or lost at least 1 or 3 lines in BCVA at 24 months;

  • proportion of participants who had CNV recurrence with subfoveal extension;

  • mean change in central foveal thickness measured by OCT;

  • systemic or ocular adverse event.


Follow‐up: 24 months
VA measurement: ETDRS chart at a distance of 4 m.
Notes Date conducted: participants enrolled from January 2006 to July 2006, and followed for 2 years
Sources of funding: not reported
Declaration of interest: not reported
Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Each patient was randomly allocated to 1 of the 3 treatment groups through a computer‐generated number."
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "At each scheduled examination, a complete ophthalmological assessment was carried out by an investigator who had had no previous contact with the subject and was unaware of the treatment previously administered."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no loss to follow‐up.
Selective reporting (reporting bias) Low risk Comment: protocol could not be found but outcome measures were specified in the methods section.
Other bias Low risk Comment: no other bias identified.