| Eligibility |
Inclusion Criteria:
1. Male or female aged 55-80 years at the time of signing the informed consent form.
2. 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.
Or
• 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.
3. 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.
4. Willing, committed, and able to return for clinic visits and complete all
study-related procedures.
5. 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:
1. Any prior ocular or systemic anti-VEGF therapy, during the past three months,
Photodynamic Therapy (PDT) or surgery for neovascular AMD.
2. 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)
3. 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.
4. The presence of scar, fibrosis, or atrophy in the central part of the fovea in the
study eye.
5. The presence of retinal pigment epithelial tears or rips involving the macular part of
the study eye at the time of entering the study.
6. The history of any vitreous hemorrhage within four weeks prior to the first visit of
the study in the study eye.
7. 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.
8. Clinical or paraclinical diagnosis of PCV by the physician at baseline
9. 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.
10. Prior vitrectomy in the study eye.
11. History of retinal detachment or treatment or surgery for retinal detachment in the
study eye.
12. Any history of a macular hole of stage two or above in the study eye.
13. 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.
14. Prior trabeculectomy or any other filtration surgery in the study eye.
15. Uncontrolled glaucoma (defined as intraocular pressure = 25 mmHg despite treatment
with anti-glaucoma medication) in the study eye.
16. Active intraocular inflammation in either eye.
17. Active ocular or periocular infection in either eye
18. Any ocular or periocular infection within the last two weeks prior to screening visit
in either eye.
19. Any history of uveitis in either eye.
20. Presence or history of scleromalacia in either eye.
21. Aphakia or pseudophakia with the absence of posterior capsule (unless it occurred as a
result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye.
22. Previous therapeutic radiation in the region of the study eye.
23. History of corneal transplant or corneal dystrophy in the study eye.
24. Any significant media opacities, including cataract, in the study eye that might
interfere with visual acuity, assessment of drug safety, or fundus photography.
25. Patients with amblyopia.
26. Patients with blindness in the opposite eye (if for any reason, the patient's vision
in the opposite eye is limited to understanding the light and movement of the hands,
the patient should not enter the study, but if the best-corrected visual acuity index
is 20/400 or more, it is not a problem).
27. Any concurrent intraocular condition in the study eye that, in the opinion of the
investigator, could require either medical or surgical intervention during the study
period.
28. Any concurrent ocular condition in the study eye which, in the opinion of the
investigator, could either increase the risk to the patient beyond what is to be
expected from standard procedures of intraocular injection, or which otherwise may
interfere with the injection procedure or with evaluation of efficacy or safety.
29. History of other diseases, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the patient at high risk for
treatment complications.
30. Participation as a patient in any clinical study within the 12 weeks prior to the
screening visit.
31. The use of long-acting steroids, either systemically or intraocularly, in the six
months prior to screening visit.
32. Any history of allergy to povidone iodine.
33. Females who are pregnant, breastfeeding, planning to become pregnant during the study
period, unwilling to practice adequate contraception throughout the study and for at
least 60 days following the last dose of study medication.
34. History of stroke, myocardial infarction or uncontrolled hypertension (blood pressure
>160/100 despite receiving medical treatment) for less than three months from the date
of the Screening visit.
35. Evidence of significant uncontrolled concomitant diseases such as cardiovascular
disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal
disorders.
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