Phase 1 Trial Of Bevacizumab Treatment For Severe ROP (ROP1)

Injection Procedure Manual V2.1 (Protocol Version 3.0 11/28/16)

Version History

The following table outlines changes for the study drug procedure:

Version
Number / Author / Approver / Effective Date / Revision Description /
1.0 / R. Kraker / B. Fimbel / 2/15/15 / Initial
2.0 / R. Kraker / B. Fimbel / 2/23/16 / Updated pre-injection procedure for verification of eye to receive injection to remove placing a mark on the infant.
2.1 / B. Fimbel / R. Kraker / 2/9/17 / Revised procedures manual header with updated protocol version. Added version history section. Injection procedure was unchanged.
Revised document sent with cover letter to sites reminding them that the procedure remains unchanged.

A.  Intravitreal Injection Procedure

The bevacizumab injection will be given preferably within 24 hours, but no later than 72 hours, after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreal injection in the operating room or at the bedside, with or without anesthesia given after consultation with the institutional neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated.

The investigator who gives the injection must have previous experience giving intravitreal injections. If the injection is the first given by the investigator for ROP, then it must be given with the assistance of an ophthalmologist who has previously given intravitreal injections for ROP.

Pre-Injection:

·  For each eye to be treated, the treating investigator and a second person will review the Bevacizumab Study Syringe Label to confirm which eye will receive the intravitreal injection.

·  Two individuals (other than the treating investigator) must confirm the label information on the study syringe to be used for injection matches the information on the Bevacizumab Study Syringe Preparation Form prior to injection to ensure accuracy.

Injection protocol is as follows:

  • Topical anesthesia is applied to the ocular surface prior to treatment (Tetracaine, Proparacaine, or 4% Lidocaine).
  • A drop of diluted betadine is applied to the ocular surface.
  • The eye lids are scrubbed with betadine.
  • A small, wire eyelid speculum is placed to hold the eyelids open.
  • The fornices (loose arching folds connecting the conjunctival membrane lining the inside of the eyelid with the conjunctival membrane covering the eyeball) are treated with topical betadine.
  • The drug (either 10 µl or 25 µl total volume, depending on dose) is injected through the temporal sclera (the outer white part of the eye) into the vitreous cavity 1.0 to 2.0 mm posterior to the limbus with a 30-gauge needle.
  • A sterile cotton swab is used to stem reflux of drug while removing the needle.
  • Topical antibiotic may be used at the discretion of the investigator pre- and post-injection.

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