None listed
Conditions
Brief summary
Hypothesis: Injection of Bevacizumab into the eye can help in patients who did not respond completely to the laser treatment. Methods: Patient Recruitment: Patients with proliferative diabetic retinopathy who had undergone PRP therapy at least 6 months prior to study recruitment with documented residual NV activity are invited to participate in the study. Patients evaluation: The initial visit comprises a complete medical history and a comprehensive eye examination including posterior biomicroscopy and indirect ophthalmoscopy. Stereo fundus imaging to evaluate the neovascular activity. Intravitreal injection: standardized intravitreal injection is done _published protocols available online_ briefly, after wearing sterile gloves, scrubbing the eyelids with betadine, a sterile lid speculum is applied. Anesthesia is achieved with procaine eye drops (Cebesine 0.4% ). Bevacizumab, at a dose of 1.25mg in 0.05 cc is injected into the vitreous cavity 3.5 mm from the limbus in the superotemporal area using a 30 gauge needle. This procedure is repeated on a monthly basis aiming at NV regression, which is evaluated using stereo fundus photography. When the NV’s become smaller in size and caliber and inactive or if a tractional component starts to develop, the injections would be withheld and the fundus would be observed with serial monthly photography until study closure. If NV activity is re-documented, then injections would resume on a monthly basis as long as traction is not present.
Interventions
monthly intravitreal injection of 0.05 cc or 1.25 mg of Bevacizumab by a retina specialist, the intravitreal injection is done in a minor operating room. After scrubbing the eyelids with betadine, and application of a sterile speculum, one drop of Cebesine 0.4% is instilled to ensure anesthesia. at 3.5 mm from limbus in the inferotemporal quadrant 0.05 cc of 125 mg of Bevacizumab are injected into the vitreous pointing the 30 gauge needle towards the macula.. This, in addition to stereo fundu
monthly intravitreal injection of 0.05 cc or 1.25 mg of Bevacizumab by a retina specialist, the intravitreal injection is done in a minor operating room. After scrubbing the eyelids with betadine, and application of a sterile speculum, one drop of Cebesine 0.4% is instilled to ensure anesthesia. at 3.5 mm from limbus in the inferotemporal quadrant 0.05 cc of 125 mg of Bevacizumab are injected into the vitreous pointing the 30 gauge needle towards the macula.. This, in addition to stereo fundus photography are top be repeated on a monthly basis until either quiescence of neo-vascular activity happens or traction starts to develop or the period of study has finished., Both quiescence or traction are assessed the stereo photography and a Berzin viewer,
Sponsors
Haytham Salti
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Complete pan retinal photocoagulation laser treated proliferative diabetic retinopathy 6 months prior to presentation, with evidence of residual neovascular activity documented by stereo fundus photography. Willingness to sign consent form. Willingness to get an intravitreal injection (or multiple ones scheduled on a monthly basis); Willingness to come every month for evaluation.
Exclusion criteria
diagnosis of glaucoma, history of cerebrovascular accidents, evidence of retinal traction and the presence of media opacity hindering proper fundus photo imaging.
Outcome results
None listed