Table 3.

Measurement and Examination Procedures for Scheduled Study Evaluations

Visit		E-ETDRS		SD- OCT	IOP	Ophthalmic exam*	Lens Exam	Fundus Photos**	NEI VFQ-25	Treatment***	Ultra- widefield FA****
	Medical	Refraction	Visual Acuity
Screening/randomization	X	X	X	X	X	X	X	X	X	Bev or Afl	X
Primary Outcome Period
At Months 1, 2, 3, 4, and 5			X	X	X	X				Bev or Afl
At Month 6		X	X	X	X	X	X	X	X	Bev or Afl or Dex	X
Secondary Outcome Period
Good Responders
Months 7, 8, 9, 10, and 11, or TAE			X	X	X	X				Bev or Afl
Poor or Marginal Responders in Afl arm
Month 6, PRN at Month 9, 10, or 11			X	X	X	X				Dex
Poor or Marginal Responders in Bev arm
Months 6, 7, 8 and TAE			X	X	X	X				Afl
At Month 12		X	X	X	X	X	X	X	X		X

E-ETDRS = electronic Early Treatment Diabetic Retinopathy Study. SD-OCT = Spectral Domain optical coherence tomography. IOP = intraocular pressure. FA = Fluorescein angiogram. TAE=Treat and Extend. Bev=bevacizumab. Afl=aflibercept. Dex=Dexamethasone.

^*Includes both a dilated fundus examination and a slit-lamp examination.

^**Modified 3-Field photos on study eye only.

^***Injection treatment between Months 1 and 5 is Bev or Afl, depending on initial randomization assignment. Good responders continue Bev or Afl on monthly or TAE schedule between Months 7 and 11 according to secondary randomization. Dex provided at Month 6 and PRN at Month 9, 10 or Month 11 in Poor or Marginal Responders initially randomized to Afl. Afl provided at Months 6, 7, 8 and TAE in Poor or Marginal Responders initially randomized to Bev.

^****Ultra-widefield FA performed at a subgroup of sites that have this ability.