Exudative age-related macular degeneration, diabetic macular edema, macular edema associated with venous occlusion, secondary choroidal neovascularization associated with myopia
Conditions
Interventions
Group 1: Patients with exudative age-related macular degeneration who receive intravitreal drug administration (IVOM) are assessed at study enrollment and at 12 and 24 months regarding their overall h
Sponsors
Augenklinik und Poliklinik der Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Patients diagnosed with (study eye): • Exudative age-related macular degeneration (H35.30) • Macular edema associated with diabetic retinopathy (H36.0) • Macular edema associated with venous occlusion (H34.8; H34.2) • Secondary choroidal neovascularization associated with myopia (H31.8) -Sufficient knowledge of German to complete the questionnaires -The patient has given consent to participate in the study, and a signed informed consent form is on file before any study-related procedures are performed.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Presence of other relevant ophthalmic conditions that could influence the assessment of the study endpoints, including: • Presence of other retinal diseases (e.g., central serous chorioretinopathy) • Glaucoma • Ocular surface disease (e.g., corneal scarring, severe dry eye symptoms associated with Sjögren’s syndrome) • Active or recurrent ocular inflammation (e.g., clinically significant blepharitis, conjunctivitis, scleritis, keratitis, or uveitis) -History of photodynamic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of changes in health-related quality of life among IVOM patients after 12 months compared to baseline, as measured using the EQ-5D questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Investigation of changes in vision-related quality of life among IVOM patients after 12 months compared to baseline, as measured by the NEI-VFQ-25 questionnaire. • Investigation of changes in anxiety symptoms among IVOM patients after 12 months compared to baseline, as measured using the GAD-7 questionnaire. • Identification of factors associated with stable or declining quality of life, as well as changes in anxiety symptoms, over the course of the 12-month treatment period. • Furthermore, a follow-up assessment of changes in quality of life and anxiety symptoms, as well as the associated treatment factors, is planned after 24 months. | — |
Countries
Germany
Contacts
Public ContactPeter Wolfrum
Augenklinik und Poliklinik der Universitätsmedizin Mainz
Outcome results
None listed