VIEW Trials: Aflibercept Every Eight Weeks in AMD

The VIEW trials tested aflibercept against monthly ranibizumab in neovascular age-related macular degeneration.

They showed that aflibercept every eight weeks gave the same vision outcomes with fewer injections.

Therefore, they changed how clinicians plan the treatment burden for patients.

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Background to the VIEW Trials

MARINA and ANCHOR showed that monthly ranibizumab improved vision in neovascular AMD.

Monthly injections place a heavy burden on patients and clinics.

Also, aflibercept binds VEGF with high affinity, so it may last longer (see anti-VEGF therapy).

The trial sponsors set out to test this idea.

Design of the VIEW Trials

VIEW 1 enrolled patients in the United States and Canada, and VIEW 2 enrolled patients in other regions.

Together, they included about 2400 patients.

Participants received aflibercept 0.5 mg monthly, 2 mg monthly, or 2 mg every eight weeks after three monthly doses, or ranibizumab 0.5 mg monthly.

Also, the primary endpoint was noninferiority for maintaining vision at 52 weeks.

Results of the VIEW Trials

Heier and colleagues reported that about 95 percent of patients in every arm kept vision.

Mean gains were close to 8 to 9 letters in each arm.

Also, the every-eight-weeks arm needed about eight injections in the first year, compared with twelve or more for monthly dosing.

As a result, the burden fell without a loss of vision.

Second-Year Findings in the VIEW Trials

Schmidt-Erfurth and colleagues reported 96-week results.

Patients entered a capped as-needed phase with visits every four weeks and a minimum injection interval of 12 weeks.

Vision gains held, and the average number of injections was low (see intravitreal injection therapy).

Safety in the VIEW Trials

Ocular and systemic safety were similar between aflibercept and ranibizumab.

Also, the rates of endophthalmitis and cardiovascular events did not differ clearly.

Therefore, aflibercept was approved for use every eight weeks after loading.

Impact of the VIEW Trials on Practice

Many clinics adopted fixed eight-week dosing, and later treat-and-extend schedules.

Also, the trials set a model for noninferiority designs in later drug studies.

Because longer intervals reduce visits, they help patients who travel far for care.

Limits of the VIEW Trials

Both studies were sponsored and masked, and they excluded some patients with prior treatment.

Also, they did not compare with bevacizumab (see age-related macular degeneration).

Counselling Caregivers

Many patients depend on a relative to bring them to visits.

Also, fewer injections mean fewer days lost from work.

Because caregiver strain affects adherence, discuss the schedule with the family.

Practical Scheduling

Plan the next visit before the patient leaves the clinic.

Then send a reminder one week ahead.

Also keep a list of patients who miss visits, and call them promptly.

Take-Home Message

Aflibercept achieved the same vision with fewer injections.

Also, the trials gave the field a model for noninferiority studies.

Because the schedule is lighter, adherence is easier for patients and clinics.

Therefore, consider the interval when you plan treatment.

From Fixed Dosing to Treat and Extend

After VIEW, clinicians began to extend intervals according to disease activity.

Also, treat-and-extend schedules maintain vision with a variable number of injections.

Therefore, the trials supported both fixed and flexible plans.

Because patients differ, choose the plan that fits the individual.

Higher-Dose Aflibercept

Later studies tested a higher dose that allowed intervals of 12 and 16 weeks.

Also, the results showed noninferior vision in many patients.

Therefore, injection burden can fall further in eligible patients.

Why Fewer Injections Matter

Each injection carries a small risk and requires a visit.

Also, caregivers must take time off work to bring patients.

Because adherence falls with frequent visits, longer intervals help vision.

Therefore, the VIEW design had real benefit for practice.

Patient Counselling

Explain the loading phase and the later schedule in plain language.

Also, describe symptoms that need urgent review, such as pain or reduced vision.

Because treatment continues for years, set expectations early.

Interpreting the Noninferiority Margin

The trials used a margin of 10 percent for the proportion that kept vision.

Also, noninferiority does not mean that the drugs are identical.

Therefore, read the secondary outcomes, such as the mean gain and anatomic results.

Key Points for the Clinician

Aflibercept every eight weeks matched monthly ranibizumab.

Also, the safety profile was similar.

Because the schedule is lighter, it suits many patients.

For the latest studies, see the PubMed results for VIEW trials.

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References

1. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119:2537-2548.
2. Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121:193-201.
3. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419-1431.
4. Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432-1444.