Neovascular age-related macular degeneration (nAMD) with pigment epithelial detachment (PED)
Conditions
Interventions
8 mg aflibercept treatment group:None
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 50 years; 2. Clinical diagnosis of neovascular age-related macular degeneration (nAMD) with pigment epithelial detachment (PED), including serous, fibrovascular/hemorrhagic, and mixed PED, with a minimum PED height and width > 100 µm; 3. Planned to receive intravitreal injection of 8 mg aflibercept as routine clinical treatment; 4. Signed patient informed consent obtained before the start of data collection.
Exclusion criteria
Exclusion criteria: 1. Currently participating in other interventional clinical trials; 2. Drusenoid PED; 3. Presence of contraindications to 8 mg aflibercept, including allergy to the active ingredient or excipients, active ocular infection, severe active intraocular inflammation, etc. 4. Presence of external/periocular infection or inflammation in either eye at the time of the first injection; 5. The fellow eye is receiving intravitreal injection therapy with agents other than aflibercept; 6. The study eye has received intravitreal corticosteroid therapy within the past 3 months; 7. The study eye has received a dexamethasone intravitreal implant within the past 6 months; 8. The study eye currently has any drug sustained-release implant; 9. The study eye has uncontrolled glaucoma (defined as intraocular pressure [IOP] > 25 mmHg despite treatment with anti-glaucoma medication); 10. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in central subfield thickness from baseline to month 12;Mean change in maximum pigment epithelial detachment height from baseline to month 12;Mean change in maximum pigment epithelial detachment width from baseline to month 12;Change in best-corrected visual acuity from baseline to month 12;Mean change in pigment epithelial detachment area from baseline to month 12;Mean change in pigment epithelial detachment volume from baseline to month 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of eyes without central macular intraretinal fluid and subretinal fluid at months 6 and 12;Proportion of eyes with pigment epithelial detachment resolution or improvement at months 6 and 12;Change in central subfield thickness from baseline to months 1, 2, 3, 6, 9, and 12;Number of visits within 6 and 12 months;Number of patients with adverse events, serious adverse events, drug-related adverse events, and serious drug-related adverse events;Change in central macular intraretinal fluid volume from baseline to months 1, 2, 3, 6, 9, and 12;Change in central macular subretinal fluid volume from baseline to months 1, 2, 3, 6, 9, and 12;Number of intravitreal aflibercept 8 mg injections in the study eye within 6 and 12 months;Change in best-corrected visual acuity from baseline to months 1, 2, 3, 6, 9, and 12;Proportion of eyes by last dosing interval at months 6 and 12; | — |
Countries
China
Contacts
Public ContactMeixia Zhang
West China Hospital of Sichuan University
Outcome results
None listed