Diabetic macular oedema clinician questionnaire

Throughout this questionnaire we are interested in your experiences of and, if possible, your longer-term expectations of using treatments for diabetic macular oedema (DMO). If you do not feel comfortable providing an answer to a question please leave this blank and move on to the next question.

Your clinic:

To help us understand your answers please provide the following information:

Question 1:

How many DMO patients do you currently have registered with your practice? ______

Question 2:

Please specify all treatments which you currently use in your practice for the treatment of diabetic macular oedema (DMO) (please X all that apply):

Treatment / Used currently?
Laser
Ranibizumab (Lucentis®)
Fluocinolone acetonide intravitreal implant (Iluvien®)
Dexamethasone intravitreal implant in applicator (Ozurdex®)
Bevacizumab (Avastin®)
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Question 3: If you have stated that you currently use bevacizumab:

a)  In the last 6 months, how many DMO patients have you treated with bevacizumab? ______

b)  What is the most common reason for prescribing bevacizumab? ______

c)  Given the fact that bevacizumab is not licensed for intraocular use, does its prescription add to the burden of DMO treatment in any way? ______

Please provide answers for dexamethasone and for the treatments which you currently use in your practice, leaving those which you do not use blank. Throughout, treatments will be referred to by their generic name.

Bilateral DMO:

The following questions consider the treatment of patients with bilateral DMO.

Question 4:

Please estimate the percentage of new patients who present to your clinic with bilateral DMO ______

Question 5:

If a patient presents with (or develops) bilateral DMO

a)  Would you treat both eyes of the patient? (please X one)

Yes / Please go to part c)
No / Please go to part b)

b)  If you answered no to part a), would you treat the better-seeing eye or the worse-seeing eye as a priority? (please X one)

Better-seeing eye
Worse-seeing eye

c)  If you answered yes to part a)

i.  Would the same treatment be administered to both eyes? (please X one)

Yes
No

ii.  Would both eyes be treated in the same visit or would a separate visit need to be scheduled for each eye? (please X one)

Both eyes would be treated at the same visit
A separate visit would be needed for each eye

Question 6:

If a patient presents with unilateral DMO and then later develops DMO in their second eye, what would you expect the duration of treatment in the second eye to look like in comparison to the initially affected eye? (please X one)

Shorter duration
The same duration
Longer duration

Treatment setting:

The following questions consider the setting of treatment of patients with DMO.

Question 7:

Intravitreal injection procedures may be performed in an outpatient or a day case setting. For each type of intravitreal injection, please indicate the percentage of procedures with this intravitreal injection which are performed in an outpatient and day case setting in your clinic. (Percentages in each row should sum to 100%)

Treatment / Percentage outpatient procedures / Percentage day case procedures
Example (A% + B% = 100%) / A% / B%
Ranibizumab / XX% / XX%
Fluocinolone acetonide / XX% / XX%
Dexamethasone / XX% / XX%
Bevacizumab / XX% / XX%
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Monitoring requirements:

The following questions consider the monitoring requirements of patients with DMO.

Question 8:

Patients with DMO are expected to require a number of visits and tests as part of their routine monitoring. Please complete the following tables indicating the numbers of different type of visits and tests DMO patients receive (on average) in each year from the initiation of treatment in practice:

Patients receiving no treatment for DMO
Resource / Number required in
Year 1 / Year 2 / Year 3 / Year 4 / Annually in Year 5+
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Patients receiving laser for DMO
Resource / Number required in
Year 1 / Year 2 / Year 3 / Year 4 / Annually in Year 5+
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Patients receiving ranibizumab for DMO
Resource / Number required in
Year 1 / Year 2 / Year 3 / Year 4 / Annually in Year 5+
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Patients receiving fluocinolone acetonide for DMO
Resource / Number required in
Year 1 / Year 2 / Year 3 / Year 4 / Annually in Year 5+
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Patients receiving dexamethasone for DMO
Resource / Number required in
Year 1 / Year 2 / Year 3 / Year 4 / Annually in Year 5+
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Patients receiving bevacizumab for DMO
Resource / Number required in
Year 1 / Year 2 / Year 3 / Year 4 / Annually in Year 5+
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Question 9:

Of the resources listed, please indicate whether they:

a)  May be performed as part of a treatment visit

b)  May be performed in a visit which combines multiple resources (if not a treatment visit)

c)  Require a separate visit, but may be performed on the same day as other visits

Resource / Please X the resources (if any) which
May be performed as part of a treatment visit / May be performed in a visit which combines multiple resources / Require a separate visit, but may be performed on the same day as other visits
Ophthalmology consultation
Optical coherence tomography
Fluorescein angiography
Ophthalmoscopy
Tonometry
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Treatment and outcomes beyond observed data:

No clinical trials for the treatments for DMO have followed patients for longer than 3 years; however it is believed that some patients would require treatment beyond this period. The following questions consider the expected treatment and outcomes of patients after Year 3.

Question 10:

For patients who have received treatment (as needed) for 3 years (i.e. patients who have not discontinued from treatment)

a)  How many treatments (on average) would you expect patients to require in Years 4 and 5?

Treatment / Number of treatments needed in Year 4 / Number of treatments needed in Year 5
Laser
Ranibizumab
Fluocinolone acetonide
Dexamethasone
Bevacizumab
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

b)  How would you expect the rate of discontinuation from treatment due to lack or loss of efficacy to change in Years 4 and 5 relative to Year 3? (please X one)

It would decrease
It would stay the same
It would increase

c)  How would you expect the rate of discontinuation from treatment due to adverse events to change in Years 4 and 5 relative to Year 3? (please X one)

It would decrease
It would stay the same
It would increase

Question 11:

For patients who remain on treatment beyond Year 3 how would you expect the efficacy of treatment to change in Years 4 and 5 relative to Year 3? (Please X one)

It would decrease
It would stay the same
It would increase

Question 12:

An economic model for treatments for DMO which is under development considers an initial treatment period of fixed duration, after which it is assumed that treatment ceases.

a)  For patients who do not discontinue from treatment during this initial treatment period, how would you expect the best-corrected visual acuity of patients to change once treatment ceases?

It would decrease (please proceed to Q13)
It would stay the same (please proceed to Q13)
It would increase (please proceed to Q13)
It would differ for different treatments (Please proceed to Q12b)

b)  For the different treatments listed below, for patients who do not discontinue from treatment during this initial treatment period, how would you expect the best-corrected visual acuity of patients to change once treatment ceases?

Treatment / It would decrease / It would stay the same / It would increase
Laser
Ranibizumab
Fluocinolone acetonide
Dexamethasone
Bevacizumab
Other (please specify)*
Other (please specify)*

*Please feel free to add more rows to the table as necessary

Anti-VEGF treatment:

The following questions consider the use of anti-VEGF treatments in the real world.

Question 13:

The summary of product characteristics for ranibizumab states

“Treatment is given monthly and continued until maximum visual acuity is achieved i.e. the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment. If there is no improvement in visual acuity over the course of the first three injections, continued treatment is not recommended. Thereafter patients should be monitored monthly for visual acuity.”

This suggests that patients may be treated with up to 12 ranibizumab injections in a year and that all patients receiving ranibizumab should be monitored on a monthly basis.

a)  In your practice how many ranibizumab injections on average will a DMO patient receive in each year from the initiation of treatment? (Please provide information for as many years as you have experience of using ranibizumab)

Year 1 / Year 2 / Year 3 / Year 4 / Year 5
Number of ranibizumab injections

a)  In your practice how many monitoring visits on average will a patient receiving ranibizumab for DMO have in each year from the initiation of treatment? (Please provide information for as many years as you have experience of using ranibizumab)

Year 1 / Year 2 / Year 3 / Year 4 / Year 5
Number of ranibizumab treatments

Thank you for taking the time to complete the questionnaire.

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