Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema

Browse trials for

• Macular Edema 841
• Diabetic Retinopathy 773

Keywords

• Diabetic Macular Edema

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 402 is above the median of 97 across 163 observational studies indexed under Macular Edema.

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Study population

Groups and cohorts

• Previously treated patient

  Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept

  Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Naïve patient

  Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept

  Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Entire study population

  Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept

  Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

• DrugAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

  Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Primary outcomes

1. Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients

   Time frame: At baseline and 12 months

Secondary outcomes

1. Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population

   Time frame: At baseline and 12 months

2. Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups

   Time frame: At baseline and 24 months

3. Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups

   Time frame: At baseline and 12 months

4. Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups

   Time frame: At baseline and 24 months

5. Type of the previous treatment(s) in previously treated patients

   i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids

   Time frame: At baseline

6. Duration (months) of the previous treatment in previously treated patients

   Time frame: At baseline

7. Date of the last administered treatment in previously treated patients

   Time frame: At baseline

8. Reason for starting intravitreal aflibercept

   i.e: clinically significant macular edema conducting to a decrease of visual acuity, early care of DME, laser photocoagulation or vitrectomy not indicated, diabetes care not optimized

   Time frame: At baseline, 12 months and 24 months

9. Number of eyes injected

   Time frame: Up to 24 months

10. Number of visits with injection

    Time frame: Up to 24 months

11. Interval (days) between injections

    Time frame: Up to 24 months

12. Type of adjunctive therapy post IVT aflibercept initiation

    i.e: surgery, focal laser, steroids, etc

    Time frame: Up to 24 months

13. Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups

    Time frame: At baseline and 24 months

14. Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups

    Time frame: At baseline and 24 months

15. Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up

    Time frame: At baseline, 12 months and 24 months

16. Mean change in HbA1c level during macular disease monitoring

    HbA1c: Glycated haemoglobin A1c

    Time frame: At baseline, 12 months and 24 months

17. Mean change in blood pressure during macular disease monitoring

    Time frame: At baseline, 12 months and 24 months

18. Duration of the disease (DME Monitoring)

    Time frame: At baseline

19. Number of visits for monitoring only (DME Monitoring)

    Time frame: Up to 24 months

20. Number of visits for injection only (DME Monitoring)

    Time frame: Up to 24 months

21. Number of visits combining monitoring and injection (DME Monitoring)

    Time frame: Up to 24 months

22. Number of monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring)

    Monitoring visits for diabetes by diabetologists or general practitioners outside the study center

    Time frame: Up to 24 months

23. Number of visits with OCT assessments (DME monitoring)

    Time frame: Up to 24 months

24. Number of visits with fundus photography assessments (DME monitoring)

    Time frame: Up to 24 months

25. Number of visits with fluorescein angiography assessments (DME monitoring)

    Time frame: Up to 24 months

26. Number of visits with visual acuity measurements (DME monitoring)

    Time frame: Up to 24 months

27. Number of participants with ocular and non-ocular safety events

    Time frame: Up to 24 months

Other outcomes

1. Number of prior treatments (DME Monitoring)

   Time frame: Up to 24 months

2. Number of patients with prior photocoagulation laser therapy (DME Monitoring)

   Time frame: Up to 24 months

3. Number of patients with prior anti-VEGF treatment (DME Monitoring)

   Time frame: Up to 24 months

4. Number of patients with prior intraocular steroids (DME Monitoring)

   Time frame: Up to 24 months

Publications

• Korobelnik JF, Daien V, Faure C, Tadayoni R, Giocanti-Auregan A, Dot C, Kodjikian L, Massin P; APOLLON study investigators. Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. Sci Rep. 2022 Oct 29;12(1):18242. doi: 10.1038/s41598-022-22838-1. PubMed 36309572 ↗

Related links

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