Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial

Table 1 Schedule of visits and activities

Visits (± window)	V0	V1^b	V2^b	V3	V4	V5	V6	V7	V8	V9	V10	V11	V12
Visits (± window)	Day1	1 month ± 5 days	2 months ± 5 days	3 months ± 15 days	4 months ± 5 days	5 months ± 5 days	6 months ± 30 days	7 months ± 5 days	8 months ± 5 days	9 months ± 5 days	10 months ± 5 days	11 months ± 5 days	12 months ± 30 days
Visit duration	2 h	1 h	1 h	3 h	1 h	1 h	3 h	1 h	1 h	1 h	1 h	1 h	3 h
Complete ophthalmologic examination (slit lamp examination, IOP measurement, and ETDRS BCVA)	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Blood pressure measurement	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Blood tests	✓^a			✓^a			✓^a						✓^a
Fundus photography	✓			✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
OCT	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Indocyanine green angiography (± fluorescein angiography)	✓	✓	✓	✓			✓						✓
Quality of life questionnaire	✓^a			✓^a			✓^a						✓^a
Laser/sham laser	✓			✓
Intravitreal anti-VEGF injection	✓	✓	✓	PRN	PRN	PRN	PRN	PRN	PRN	PRN	PRN	PRN	PRN

✓ Routinely performed
✓^aProcedures specially performed for the need of the study
^bDuring the induction phase (3 anti-VEGF loading doses), examinations on visits 1 and 2 are optional, except for anti-VEGF injection that remains mandatory

ISSN: 1745-6215