Regression of resilient neovessels with monthly anti-Vascular Endothelial Growth Factor (VEGF) treatment in laser treated proliferative diabetic retinopathy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000737437
• Date of registration: 03/06/2016
• Prospective Registration: No
• Primary sponsor: Haytham Salti
• Public title: Regression of resilient neovessels with monthly anti-Vascular Endothelial Growth Factor (VEGF) treatment in laser treated proliferative diabetic retinopathy
• Scientific title: Regression of resilient neovessels with monthly anti-VEGF treatment in laser treated proliferative diabetic retinopathy
• Date of first enrolment: 11/06/2014
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000737437.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Lebanon

Contacts

• Name: Dr Maamoun Abdul Fattah

• Name: A/Prof Haytham Salti

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

diabetic retinopathy;proliferative diabetic retinopathy;
diabetic retinopathy
proliferative diabetic retinopathy

Eye - Diseases / disorders of the eye

Intervention(s)

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,

Primary Outcome(s)

quiescence of neo-vascular activity based on stereo fundus photography.[12 months after the first injection, patients will be followed on a monthly basis]

Secondary Outcome(s)

neovessel caliber, to be measured from digital fundus images using the onscreen calipers. [15 minutes each visit,. These are monthly visits for 12 times after the first injection.]

visual acuity using the ETDRS chart[Each "session" is the brief evaluation during each visit, which comprises a visual acuity testing followed by dilatation then stereo fundus photography. This is done 12 times on a monthly basis after the first injection is given. ]

Secondary ID(s)

none

Source(s) of Monetary Support

Haytham Salti

Secondary Sponsor(s)

American University of Beirut Medical Center

Ethics review

Status: Approved
Approval date:
Contact:

IRB-Military Hospital Badaro street