Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration (NCT05587062) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Iran168 participantsStarted 2019-10-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular Age-related Macular Degeneration (nAMD).
All the participants will receive one of the following regimens:
Aflibercept (CinnaGen Co, Iran) or Eylea® (Regeneron, USA), 2 mg (vial 0.05 ml) by intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8 weeks until week 48 of study.
The primary objective of this study is to verify the non-inferiority of Aflibercept (CinnaGen Co, Iran) versus Eylea® (Regeneron, USA) in achieving maintaining vision (losing\<15 letter on ETDRS chart) at week 52 in comparison to week 0 in participants with Neovascular AMD.
Who can participate
Age range55 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female aged 55-80 years at the time of signing the informed consent form.
✓. Primary active CNV subfoveal lesion secondary to AMD, with definite diagnosis of AMD, according to the physician's decision, based on the results of ocular examination, or OCT, based on the following diagnostic Criteria:
✓. The ETDRS-best-corrected visual acuity index with the score of 20/40 to 20/320 (or BCVA letter score of 73 to 25 in the study eye), which is determined by a specific trained person, within the standard distance, in each study center.
✓. Willing, committed, and able to return for clinic visits and complete all study-related procedures.
✓. Patients with the ability to read, (or, if unable to read due to visual impairment, be read by a family member or person administering the informed consent form) understand and willing to sign the informed consent form for participation in the study.
Exclusion criteria
✕. Any prior ocular or systemic anti-VEGF therapy, during the past three months, Photodynamic Therapy (PDT) or surgery for neovascular AMD.
✕. The need for receiving ocular anti-VEGF simultaneously in both eyes in the loading phase for the treatment of neovascular AMD (in fact, if the patient, in addition to the study eye, also needs to receive the drug for the opposite eye)
What they're measuring
1
The proportion of patients achieving maintaining vision at week 52
✕. Scar, fibrosis, or extensive subretinal hemorrhage of more than 50% of the total lesion area in the study eye, according to the physician's opinion based on clinical presentation or according to fundus photography.
✕. The presence of scar, fibrosis, or atrophy in the central part of the fovea in the study eye.
✕. The presence of retinal pigment epithelial tears or rips involving the macular part of the study eye at the time of entering the study.
✕. The history of any vitreous hemorrhage within four weeks prior to the first visit of the study in the study eye.
✕. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
✕. Clinical or paraclinical diagnosis of PCV by the physician at baseline