Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration

NCT05587062 | Completed Phase 3

• 1 other identifier: CIN.AFL.RK.PH3.2018
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-Related Macular Degeneration; Neovascular Age-related Macular Degeneration

Keywords

AMD; nAMD; Recombinant Fusion Protein; anti-VEGF; Aflibercept

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving maintaining vision at week 52

  Achieving maintaining vision confirmed by losing\<15 letter on ETDRS chart

  At week 52

Secondary Outcomes (6)

• Mean changes in the Best-Corrected Visual Acuity Index from week 0 to week 52

  Baseline and at week 52

• The percentage of patients who have increase of ≥15 score in ETDRS at week 52 compared to week 0

  Baseline and at week 52

• The mean change in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) at week 52 compared to week 0

  Baseline and at week 52

• Mean changes in central retinal thickness at week 52 compared to the screening visit

  Baseline and at week 52

• The percentage of patients without intra-retinal fluid and subretinal fluid at week 52

  Baseline and at week 52

Study Arms (2)

Aflibercept (CinnaGen Co, Iran)

EXPERIMENTAL

Aflibercept (CinnaGen Co, Iran) 2 mg (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

Biological: Aflibercept (CinnaGen Co, Iran)

Aflibercept (Regeneron, USA)

ACTIVE COMPARATOR

Aflibercept (Regeneron, USA) 2 mg (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

Biological: Aflibercept (Regeneron, USA)

Interventions

Aflibercept (CinnaGen Co, Iran) BIOLOGICAL

Aflibercept (CinnaGen Co, Iran) by intravitreal injection

Aflibercept (CinnaGen Co, Iran)

Aflibercept (Regeneron, USA) BIOLOGICAL

Aflibercept (Regeneron, USA) by intravitreal injection

Also known as: Eylea®

Aflibercept (Regeneron, USA)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Evaluating the presence of Submacular hemorrhage in fundus examination with the presence of any of those items mentioned in OCT including: subretinal fluid, subretinal hyper reflective material, intraretinal fluid or pigment epithelial detachment.
• Diagnosis of the following, based on the OCT evaluations:
• Presence of pigment epithelial detachment with intra-retinal fluid and subretinal fluid
• Presence of pigment epithelial detachment with intra-retinal fluid and subretinal hyper reflective material
• The presence of new vessels should be confirmed with one of the additional imaging modalities (FA or ICG or OCTA).
• In cases with any suspicious for the diagnosis of AMD, other confirmatory modalities should be used.
• 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.

You may not qualify if:

• 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
• The history or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than AMD in either eyes.
• Prior vitrectomy in the study eye.
• History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
• Any history of a macular hole of stage two or above in the study eye.
• Any intraocular or periocular surgery within three months of the screening visit on the study eye except lid surgery, which may not have taken place within one month of screening visit, as long as it's unlikely to interfere with the injection during the study.
• Prior trabeculectomy or any other filtration surgery in the study eye.
• Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication) in the study eye.

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (1)

Farabi Hospital

Tehran, Iran

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: October 19, 2022
• Study Start: October 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

IR (1)