Ocular bevacizumab, as an anti-VEGF monoclonal antibody preparation specifically designed for intravitreal injection, has a dosage regimen that directly impacts treatment precision. The standardized administration process encompasses core steps including drug preparation, aseptic technique, and injection procedure, with emphasis on close peri-injection monitoring and individualized adjustment.

1.General Administration Information

Ocular bevacizumab is intended for ophthalmic intravitreal use only and must be administered by a qualified physician. The following equipment should be prepared prior to administration: a 5-micron sterile filter needle (18G×1/2 inch), a 1 mL syringe (with 0.05 mL graduation markings), and a sterile 30G×1/2 inch injection needle.

2.Recommended Dose for Neovascular (Wet) Age-Related Macular Degeneration

The recommended dose of ocular bevacizumab is 1.25 mg (equivalent to 0.05 mL of the 25 mg/mL solution), administered by intravitreal injection once monthly (approximately every 28 days).

3.Preparation Prior to Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

This vial is for single use and for treatment of one eye only.

Under aseptic conditions, the entire volume of the ocular bevacizumab vial should be withdrawn using a 5-micron sterile filter needle (18G×1/2 inch) attached to a 1 mL syringe. After withdrawing the vial contents, the filter needle should be discarded and must not be used for intravitreal injection. It should be replaced with a sterile 30G×1/2 inch needle for intravitreal injection. Advance the syringe plunger to expel contents until the plunger tip aligns with the 0.05 mL graduation mark on the syringe.

Detailed preparation steps are as follows:

Under aseptic technique requirements, prepare the following single-use equipment (to be supplied separately): a 5-micron sterile filter needle (18G×1/2 inch), a 1 mL sterile syringe (with 0.05 mL graduation markings), a sterile injection needle (30G×1/2 inch), and alcohol swabs.

Remove the plastic protective cap from the vial and clean the top of the stopper with an alcohol swab.

Securely attach the 5-micron filter needle (18G×1/2 inch) to the syringe tip.

Push the filter needle vertically through the center of the vial stopper, ensuring the needle tip remains below the liquid surface at all times to minimize bubble formation.

Keep the vial upright and tilt slightly to facilitate complete withdrawal, and aspirate the entire volume of ocular bevacizumab.

When aspirating ocular bevacizumab, ensure the plunger is pulled back sufficiently to completely empty the fluid within the filter needle.

After aspirating the vial contents, immediately discard the filter needle; this needle must not be used for intravitreal injection.

Firmly attach the sterile 30G×1/2 inch injection needle to the syringe connector and carefully remove the needle cap vertically. Do not wipe the needle at any time.

Hold the syringe with the needle pointing upward; if bubbles are present, tap the syringe gently to bring bubbles to the top.

Hold the syringe at eye level and slowly advance the plunger until the plunger tip aligns with the 0.05 mL graduation mark on the syringe.

4.Administration Method

Intravitreal injection should be performed under strict aseptic conditions, including the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent device). Adequate anesthesia and a broad-spectrum microbicide should be administered prior to injection.

Intraocular pressure should be monitored by tonometry before and within 30 minutes after injection. Post-injection monitoring may also include immediate assessment of optic nerve head perfusion. Patients should be monitored after injection and advised to promptly report any symptoms suggestive of endophthalmitis.

Each single-dose vial is for one eye only. If treatment of the contralateral eye is required, a new vial should be used and all items in the sterile field, including syringes, gloves, drapes, speculum, filter needle, and injection needle, should be changed prior to administration to the contralateral eye.