ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000697280

Ethics application status

Approved

Date submitted

30/11/2017

Date registered

30/04/2018

Date last updated

30/04/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of the evolution of patients with vitreous hemorrhage caused by proliferative diabetic retinopathy subjected to intravitreal injection of antivascular endothelial growth factor (bevacizumab)

Scientific title

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1205-7536

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

proliferative diabetic retinopathy

vitreous hemorrhage

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

intravitreal injection of antivascular endothelial growth factor (bevacizumab) - 1,25 mg (0,05 mL) performed by ophthalmologist
Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks (based on the time recommended for treatment of other ocular pathologies with bevacizumab) with a maximum of 6 injections provided and a minimum of 3 injections ( if criteria for deferral are met, that is reabsorption of vitreous hemorrhage that allows photocoagulation) until six months of follow-up,

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

simulated intravitreal injections -

Initial simulated injection (there is no actual injection, only simulation with needle-free syringe complete with air) , must be given on the day of randomization. Follow-up simulated injections will be performed as often as every 4 weeks unless criteria for deferral are met, until six months of accompaniment

Control group

Placebo

Outcomes

Primary outcome [1]

Absorption of vitreous hemorrhage enabling photocoagulation (Classification 0-2 according to the table below)

5- No vision of retina or optic disk
4- Optic disk view only
3- Vision of optic disk and large arcade vases, without conditions for photocoagulation
2- Vitreous hemorrhage located by quadrant with retinal and vases vision enough to make laser in 1-2 quadrants
1- Vitreous hemorrhage located by quadrant with retinal and vases vision enough to make laser in 3-4 quadrants
0- Peripheral vitreous hemorrhage that does not prevent laser

Timepoint [1]

at six months after randomisation

Primary outcome [2]

Percentage of patients who did not need vitrectomy (with a vitrectomy required if vitreous hemorrhage classification equal or more than a score of 3 according to the table below).

5- No vision of retina or optic disk
4- Optic disk view only
3- Vision of optic disk and large arcade vases, without conditions for photocoagulation
2- Vitreous hemorrhage located by quadrant with retinal and vases vision enough to make laser in 1-2 quadrants
1- Vitreous hemorrhage located by quadrant with retinal and vases vision enough to make laser in 3-4 quadrants
0- Peripheral vitreous hemorrhage that does not prevent laser

Timepoint [2]

at six months after randomisation

Secondary outcome [1]

Change in classification of vitreous hemorrhage greater than 2 stages (according to the table below)

5- No vision of retina or optic disk
4- Optic disk view only
3- Vision of optic disk and large arcade vases, without conditions for photocoagulation
2- Vitreous hemorrhage located by quadrant with retinal and vases vision enough to make laser in 1-2 quadrants
1- Vitreous hemorrhage located by quadrant with retinal and vases vision enough to make laser in 3-4 quadrants
0- Peripheral vitreous hemorrhage that does not prevent laser

Timepoint [1]

After six months of follow-up

Secondary outcome [2]

Change in visual acuity (better corrected visual acuity more than or equal to 20/40) based on visual acuity test

Timepoint [2]

After six months of follow-up

Eligibility

Key inclusion criteria

Diabetic patients Type 1 or type 2 with worsening of visual acuity (better corrected visual acuity less than or equal to 20/40) caused by vitreous hemorrhage with evolution without improvement of at least 30 days.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presence of tractional retinal detachment evidenced by ultrasound
Ocular inflammation or active infection (conjunctivitis, keratitis, swollen, scleritis, endophthalmitis)
Prior treatment with Antiangiogênico with less than 30 days
Vitrectomy via pars plane prior
Concomitant retinal disease that may interfere with the analysis of the final results ( macular hole, venous occlusion, AMD)
Known sensitivity to the drug used in the study

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)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The patients will be randomized as follows:
Sum of the patient's birth date: (dd + mm + yyyy)
-If the sum is a even number: Bevacizumabe injection
-If the sum is an odd number: simulated injection

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

30/05/2017

Date of last participant enrolment

Anticipated

31/07/2018

Actual

Date of last data collection

Anticipated

31/01/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Brazil

State/province [1]

São Paulo/Sorocaba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hospital Oftalmológico de Sorocaba

Address [1]

Rua Nabeck Shiroma 210, Sorocaba, SP, 18031-060

Country [1]

Brazil

Primary sponsor type

Hospital

Name

Hospital Oftalmológico de Sorocaba

Address

Hospital Oftalmológico de Sorocaba - Rua Nabeck Shiroma 210, Sorocaba, SP, 18031-060

Country

Brazil

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

88 - Hospital Oftalmológico de Sorocaba/SP

Ethics committee address [1]

Rua Nabeck Shiroma, 210, Sorocaba-SP

Ethics committee country [1]

Brazil

Date submitted for ethics approval [1]

19/04/2017

Approval date [1]

02/05/2017

Ethics approval number [1]

Summary

Brief summary

The microvascular complications of diabetes mellitus in the retina, defined as diabetic retinopathy (RD), constitute one of the main causes of blindness of the economically active population in Brazil and the world. Macular edema is the main cause of low visual acuity, however the proliferative form of RD is that it relates more frequently to severe visual loss.

The presence of vitreous hemorrhage in patients with proliferative diabetic retinopathy is one of the main causes of severe visual acuity low in these patients.	

Vitreous hemorrhage that evolves without spontaneous absorption can significantly affect visual rehabilitation and require additional surgical procedures for improvement of the vision.

The growth factor endothelial (VEGF) is expressed in high levels in the retina of diabetic retinopathy patients and are directly related to the formation of new vessels. By promoting a leukocyte migration and adhesion on the wall of vascular endothelial cells, increases vascular permeability and angiogenesis, with consequent progression of diabetic retinopathy.

Inhibition of vascular growth factor may induce proliferative diabetic retinopathy regression and combat the exuding phenomenon.

Bevacizumab (Avastin; Genentech, INC, South San Francisco, CA) is a monoclonal recombinant antibody against VEGF. Intravitreal injections of bevacizumab has been widely used in the treatment of different manifestations of proliferative diabetic retinopathy, such as progressive retinopathy active, before or combined with vitrectomy via pars plana (VVPP), severe retinal neovascularization or as a preoperative adjuvant to facilitate the surgery of VVPP.
	The vitreous hemorrhage presents itself as an evolution of this rigged angiogenesis process.
	The VVPP is the gold standard treatment for vitreous hemorrhage with or without tractional retinal detachment secondary proliferative diabetic retinopathy. Despite the VVPP having a high anatomical success rate, this procedure may be associated with surgery induced complications such as recurring vitreous hemorrhage, neovascular glaucoma, tractional retinal detachment and cataract. Such complications can compromise visual results. Moreover, a significant increase in the monetary cost of treatment.
	Until the present moment, there are few works that aims to evaluate whether patients presenting vitreous hemorrhage without retinal detachment, when subjected to VEGF intravitreal injections, has higher rates of spontaneous reabsorption of hemorrhage with consequent reduction in the need for surgery indication.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Arnaldo Furman Bordon

Address

Hospital Oftalmológico de Sorocaba - Rua Nabeck Shiroma 210, Sorocaba, SP, 18031-060

Country

Brazil

Phone

+55011992982929

Fax

afbordon@terra.com.br

Contact person for public queries

Name

Renata Guarischi Amaral Valentim

Address

Hospital Oftalmológico de Sorocaba - Rua Nabeck Shiroma 210, Sorocaba, SP, 18031-060

Country

Brazil

Phone

+55011981196789

Fax

re_guarischi@hotmail.com

Contact person for scientific queries

Name

Renata Guarischi Amaral Valentim

Address

Hospital Oftalmológico de Sorocaba - Rua Nabeck Shiroma 210, Sorocaba, SP, 18031-060

Country

Brazil

Phone

+55011981196789

Fax

re_guarischi@hotmail.com

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

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Documents added automatically

No additional documents have been identified.

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