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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 289027 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic retinopathy 298441 0
proliferative diabetic retinopathy 298442 0
Condition category
Condition code
Metabolic and Endocrine 298539 298539 0 0
Eye 298540 298540 0 0
Diseases / disorders of the eye

Study type
Description of intervention(s) / exposure
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,
Intervention code [1] 294510 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group

Primary outcome [1] 298029 0
quiescence of neo-vascular activity based on stereo fundus photography.
Timepoint [1] 298029 0
12 months after the first injection, patients will be followed on a monthly basis
Secondary outcome [1] 322969 0
visual acuity using the ETDRS chart
Timepoint [1] 322969 0
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 outcome [2] 322970 0
neovessel caliber, to be measured from digital fundus images using the onscreen calipers.
Timepoint [2] 322970 0
15 minutes each visit,. These are monthly visits for 12 times after the first injection.

Key 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.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
diagnosis of glaucoma, history of cerebrovascular accidents, evidence of retinal traction and the presence of media opacity hindering proper fundus photo imaging.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis
There are no previous studies looking at resilient NV (only case reports). No sample size has been calculated. This however prompted us to aim at recruiting around 100 eyes to look into the efficacy and to look at possible 2 or 3 risk factors for such a response.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 7826 0
State/province [1] 7826 0

Funding & Sponsors
Funding source category [1] 293401 0
Self funded/Unfunded
Name [1] 293401 0
Haytham Salti
Address [1] 293401 0
American University of Beirut Medical Center
Maamari Street
Beirut, LEBANON- Riad El Solh
Country [1] 293401 0
Primary sponsor type
Haytham Salti
American University of Beirut Medical Center
Maamari Street
Beirut, LEBANON Riad El Solh
Secondary sponsor category [1] 292230 0
Name [1] 292230 0
American University of Beirut Medical Center
Address [1] 292230 0
Maamari Street
Beirut Lebanon- Riad El Solh
Country [1] 292230 0

Ethics approval
Ethics application status
Ethics committee name [1] 294852 0
IRB-Military Hospital Badaro street
Ethics committee address [1] 294852 0
1 Badaro Street, Beirut LEBANON 11-7070
Ethics committee country [1] 294852 0
Date submitted for ethics approval [1] 294852 0
Approval date [1] 294852 0
Ethics approval number [1] 294852 0

Brief summary
Hypothesis: Injection of Bevacizumab into the eye can help in patients who did not respond completely to the laser treatment.
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.

Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 65226 0
A/Prof Haytham Salti
Address 65226 0
American University of Beirut Medical Center
Maamari Street Riad El Solh
Country 65226 0
Phone 65226 0
Fax 65226 0
Email 65226 0
Contact person for public queries
Name 65227 0
Dr Maamoun Abdul Fattah
Address 65227 0
American University of Beirut
Bliss street Riad El Solh
Country 65227 0
Phone 65227 0
Fax 65227 0
Email 65227 0
Contact person for scientific queries
Name 65228 0
A/Prof Haytham Salti
Address 65228 0
American University of Beirut Medical Center
Maamari Street,
Beirut Lebanon Riad El Solh
Country 65228 0
Phone 65228 0
Fax 65228 0
Email 65228 0

No information has been provided regarding IPD availability
Summary results
No Results