Condition category
Surgery
Date applied
07/04/2020
Date assigned
15/04/2020
Last edited
09/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Glaucoma is a common eye condition where the optic nerve, which connects the eye to the brain, becomes damaged. It's usually caused by fluid building up in the front part of the eye, which increases pressure inside the eye.
Trabeculectomy is a surgical operation which lowers the intraocular pressure inside the eye (IOP) in patients with glaucoma. This is achieved by making a small hole in the eye wall (sclera).
Avoiding excessive wound healing response remains a problem, once surgery success depends on maintaining patency of the fistula and bleb filtration. Antiproliferative agents such as mitomycin C (MMC) reduce inflammation and scarring process, improving surgical outcome. However, besides the high risk of potentially complications, studies have not proven to be fully satisfactory and new therapeutic approaches more effective and safer are currently been used to augment surgery. The use of antiangiogenic factors (such as bevacizumab) has been associated with slowing this proliferative and fibrotic process after filtration surgery.
The study aims to explore this promising modality to understand if bevacizumab is an important additional agent in improving the prognosis of glaucoma filtrating surgery.

Who can participate?, What does the study involve?
Data is extracted from medical charts of patients submitted to primary trabeculectomy for open-angle glaucoma at Centro Hospitalar Universitário Lisboa Norte and Hospital dos Lusíadas between October 2015 and March 2019

What are the possible benefits and risks of participating?
None (retrospective study)

Where is the study run from?
1. Centro Hospitalar Universitário Lisboa Norte (Portugal)
2. Hospital dos Lusíadas (Portugal)

When is the study starting and how long is it expected to run for?
September 2019 to May 2020

Who is funding the study?
Centro de Estudos das Ciências da Visão - Faculdade de Medicina da Universidade de Lisboa

Who is the main contact?
Dr Patrícia José, patricialopes1@campus.ul.pt

Trial website

Contact information

Type

Public

Primary contact

Dr Patrícia José

ORCID ID

http://orcid.org/0000-0002-4523-7306

Contact details

Centro Hospitalar Universitário Lisboa Norte
Av. Prof. Egas Moniz
Lisbon
1649-035
Portugal
+351 964958859
patricialopes1@campus.ul.pt

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

20031992

Study information

Scientific title

Trabeculectomy with mitomycin C or with mitomycin C plus intracameral bevacizumab injection? A comparative study

Acronym

Study hypothesis

To analyze the benefits of using intracameral bevacizumab injection as an add on to the standard of care use of mitomycin C (MMC) in trabeculectomy.

Ethics approval

Approved 17/12/2019, Ethics Committee of Centro Hospitalar Universitário Lisboa Norte and Hospital dos Lusíadas (R. Abílio Mendes, 1500-458, Lisbon, Portugal; +351 966 184 461; knowledgecenter@lusiadas.pt), ref: n/a

Study design

Observational cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Trabeculectomy

Intervention

Data is extracted from medical charts (background history, glaucoma characteristics, baseline IOP, preoperative visual acuity, number of ocular hypotensive medication, safety parameters, follow-up from visits on day 1; at weeks 1, 4; at months 3, 6, 12 and 24 after trabeculectomy, number of postoperative IOP-lowering medication and surgical interventions). All consecutive patients from one site (Centro Hospitalar Universitário Lisboa Norte) received standard of care; all consecutive patients from the second site (Hospital dos Lusíadas) received the becavizumab as an add on to standard of care. Statistical analysis is carried out using SPSS software (Chicago, IL, version 24.0).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The absolute and qualified surgical success rate of trabeculectomy at 12 months and 24 months defined as intraocular pressure ≤18 mmHg and >5mmHg with at least 30% reduction in IOP from baseline

Secondary outcome measures

1. Intra- and postoperative complications measured using patient records
2. Additional effects of bevacizumab measured using patient records

Overall trial start date

01/09/2019

Overall trial end date

01/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients submitted to primary trabeculectomy for open-angle glaucoma between October 2015 and March 2019
2. No other previous surgeries, except uncomplicated phaco
3. ≥ 18 years and have agreed to chart review as per GDPR regulations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Review of entire set of patients within the time range (128 patients assessed for study)

Total final enrolment

128

Participant exclusion criteria

1. Pregnancy or breastfeeding
2. Combination with cataract surgery
3. History of another eye disease
4. Uncontrolled blood pressure (systolic >180 mmHg and/or diastolic >100 mmHg while a patient is at rest)
5. Severe cardiovascular disease (including a stroke or a myocardial infarction 6 months before)
6. Known allergic reaction to bevacizumab or MMC

Recruitment start date

01/10/2015

Recruitment end date

01/03/2019

Locations

Countries of recruitment

Portugal

Trial participating centre

Centro Hospitalar Universitário Lisboa Norte
Av. Prof. Egas Moniz
Lisbon
1649-028
Portugal

Trial participating centre

Hospital dos Lusíadas
R. Abílio Mendes 12
Lisbon
1500-258
Portugal

Sponsor information

Organisation

Centro Hospitalar Lisboa Norte

Sponsor details

Hospital Lusíadas
Av. Prof Egas Moniz
Lisbon
1649-028
Portugal
+351 962958859
patricialopes1@campus.ul.pt

Sponsor type

Hospital/treatment centre

Website

http://www.chln.min-saude.pt/

Funders

Funder type

University/education

Funder name

Universidade de Lisboa

Alternative name(s)

University of Lisbon, ULisboa

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Portugal

Results and Publications

Publication and dissemination plan

The results of this study should be published in a high-visibility peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/04/2020: Trial’s existence confirmed by Hospital dos Lusíadas