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 range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients achieving maintaining vision at week 52
. 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)
. 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