Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000737437
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
3/06/2016
Date last updated
3/06/2016
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
none
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
Diabetes
Eye 298540 298540 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/06/2014
Date of last participant enrolment
Anticipated
6/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 7826 0
Lebanon
State/province [1] 7826 0
Beirut

Funding & Sponsors
Funding source category [1] 293401 0
Self funded/Unfunded
Name [1] 293401 0
Haytham Salti
Country [1] 293401 0
Lebanon
Primary sponsor type
Individual
Name
Haytham Salti
Address
American University of Beirut Medical Center
Maamari Street
Beirut, LEBANON Riad El Solh
110236
Country
Lebanon
Secondary sponsor category [1] 292230 0
Hospital
Name [1] 292230 0
American University of Beirut Medical Center
Address [1] 292230 0
Maamari Street
Beirut Lebanon- Riad El Solh
110236
Country [1] 292230 0
Lebanon

Ethics approval
Ethics application status
Approved
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
Lebanon
Date submitted for ethics approval [1] 294852 0
10/04/2013
Approval date [1] 294852 0
12/03/2014
Ethics approval number [1] 294852 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65226 0
A/Prof Haytham Salti
Address 65226 0
American University of Beirut Medical Center
Maamari Street Riad El Solh
110236
Beirut
Country 65226 0
Lebanon
Phone 65226 0
+9613776683
Fax 65226 0
+9611370837
Email 65226 0
hs06@aub.edu.lb
Contact person for public queries
Name 65227 0
Maamoun Abdul Fattah
Address 65227 0
American University of Beirut
Bliss street Riad El Solh
110236
Country 65227 0
Lebanon
Phone 65227 0
+96178845330
Fax 65227 0
Email 65227 0
ma318@aub.edu.lb
Contact person for scientific queries
Name 65228 0
Haytham Salti
Address 65228 0
American University of Beirut Medical Center
Maamari Street,
Beirut Lebanon Riad El Solh
110236
Country 65228 0
Lebanon
Phone 65228 0
+9613776683
Fax 65228 0
Email 65228 0
hs06@aub.edu.lb

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.