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Trial registered on ANZCTR


Registration number
ACTRN12622000313730
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative Efficacy of Intravitreal Bevacizumab and Topical Diclofenac Combined Therapy, Intravitreal Ketorolac, and Intravitreal Bevacizumab on Diabetic Macular Edema
Scientific title
Comparative Efficacy of Intravitreal Bevacizumab and Topical Diclofenac Combined Therapy, Intravitreal Ketorolac, and Intravitreal Bevacizumab on Diabetic Macular Edema
Secondary ID [1] 304714 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic macular edema 322732 0
diabetes mellitus 322734 0
Condition category
Condition code
Eye 320321 320321 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 320322 320322 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravitreal Bevacizumab and Topical Diclofenac Combined Therapy Group, receiving 1,25 mg/0,05 ml intravitreal Bevacizumab (Avastin®; Genentech, Inc., South San Francisco, CA, USA) administered once only using 27-gauge needle through the superotemporal quadrant and then followed by administration of 1 mg/ml Diclofenac eyedrops (Noncort®; Cendo, Bandung, Indonesia) every 8 hours for a total 4 weeks; Intravitreal Ketorolac group, receiving 3000µg/0,1ml ketorolac once only (Rativol®; Sanbe Farma, Bandung, Indonesia) and then followed by administration of placebo eye drops (Sodium Chloride and Potassium Chloride), eyedrops administered every 8 hours for a total 4 weeks; Intravitreal Bevacizumab group receiving 1,25 mg/0,05 ml intravitreal Bevacizumab (Avastin®; Genentech, Inc., South San Francisco, CA, USA) administered once only using 27-gauge needle through the superotemporal quadrant and then followed by administration of placebo eye drops (Sodium Chloride and Potassium Chloride), eyedrops administered every 8 hours for a total 4 weeks. For all treatment arms, the intervention will be delivered only to one eye. Adherence/fidelity of the intervention are monitored through: hospital record during intravitreal injection which is performed by vitreoretinal surgeon, during intravitreal injection the patients do not know the injected drugs; periodic phonecall/message reminder from the assistant regarding topical diclofenac or topical placebo eyedrops administration.
Intervention code [1] 321092 0
Treatment: Drugs
Comparator / control treatment
Intravitreal Bevacizumab group, receiving only 1,25 mg/0,05 ml intravitreal Bevacizumab (Avastin®; Genentech, Inc., South San Francisco, CA, USA) and then followed by administration of placebo eye drops (Sodium Chloride and Potassium Chloride), eyedrops administered every 8 hours for a total 4 weeks.

the frequency and duration of intravitreal bevacizumab administration: once only for 4 weeks. Placebo eyedrops administered every 8 hours for a total 4 weeks.

the intervention will be delivered only to one eye
Control group
Active

Outcomes
Primary outcome [1] 328169 0
Central Macular Thickness will be measured using Optical Coherence Tomography
Timepoint [1] 328169 0
Injection Day (before administration of the intervention): (central macular thickness).
Day 28 post injection (primary endpoint: central macular thickness).
Primary outcome [2] 328170 0
Vascular endothelial growth factor (VEGF) level of tear samples
Timepoint [2] 328170 0
Injection Day (before administration of the intervention): (Vascular endothelial growth factor (VEGF) level of tear samples).
Day 28 post injection (primary endpoint: Vascular endothelial growth factor (VEGF) level of tear samples)
Primary outcome [3] 328171 0
National Eye Institute Visual Function Questionnaire (NEI VFQ) 25 Composite and Subscale Score
Timepoint [3] 328171 0
Injection Day (before administration of the intervention): (NEI VFQ)
Day 28 post injection (primary endpoint: NEI VFQ)
Secondary outcome [1] 397924 0
Best-Corrected Visual Acuity (BCVA) measured by Snellen chart recorded in logarithm of the minimum angle of resolution (logMAR) scale.
Timepoint [1] 397924 0
Injection Day (before administration of the intervention), Day 28 post injection.

Eligibility
Key inclusion criteria
Patients diagnosed with diabetic macular edema in type 2 diabetes mellitus, over 18 years of age at the time of intravitreal injection and never received anti-VEGF intravitreal injection therapy nor retinal laser therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have significant media opacities that could preclude macular ocular coherence tomography (OCT) examination, failed to receive intravitreal injection of Bevacizumab for any reason, underwent intraocular surgery during the study period, were having infection / inflammation in the anterior segment and those who were on systemic or topical corticosteroid / Non Steroid Anti Inflammation Drugs (NSAID) therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
Actual
28/05/2021
Sample size
Target
75
Accrual to date
Final
82
Recruitment outside Australia
Country [1] 23945 0
Indonesia
State/province [1] 23945 0
Yogyakarta

Funding & Sponsors
Funding source category [1] 309084 0
University
Name [1] 309084 0
Universitas Gadjah Mada
Country [1] 309084 0
Indonesia
Primary sponsor type
Individual
Name
Supanji Haryanto
Address
Gedung Rawat Jalan Lantai 5 SMF Ilmu Kesehatan Mata
RSUP Dr. Sardjito
Jalan Kesehatan No.1
Sekip Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281
Country
Indonesia
Secondary sponsor category [1] 310032 0
Individual
Name [1] 310032 0
Muhammad Bayu Sasongko
Address [1] 310032 0
Gedung Rawat Jalan Lantai 5 SMF Ilmu Kesehatan Mata
RSUP Dr. Sardjito
Jalan Kesehatan No.1
Sekip Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281
Country [1] 310032 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308958 0
Medical and Health Research Ethics Committee Faculty of Medicine, Public Health and Nursing UGM
Ethics committee address [1] 308958 0
Sekretariat Komisi Etik. Gedung Radiopoetro Lt 2 Sayap Barat,. Jl. Farmako, Sekip Utara, Yogyakarta 55128
Ethics committee country [1] 308958 0
Indonesia
Date submitted for ethics approval [1] 308958 0
10/12/2019
Approval date [1] 308958 0
06/03/2020
Ethics approval number [1] 308958 0

Summary
Brief summary
This study aim to assess the efficacy of NSAIDs in diabetic macular edema treatment regimens as primary therapy or as a complementary therapy. VEGF is a potent vasopermeability factor that has been targeted extensively in diabetic macular edema. We hypothesize that the administration of NSAID will decrease VEGF level in patients with diabetic macular edema. Included eyes underwent a full ophthalmologic examination, spectoral-domain optical coherence tomography and tear sample collection at baseline. Eyes were randomly assigned to one of the three groups, intravitreal Bevacizumab and topical Diclofenac, intravitreal Ketorolac, intravitreal Bevacizumab. The eyes received single intravitreal injection throughout the study period. Patients were given questionnaire NEI VFQ25. The follow up consist of complete ophthalmologic examination and questionnaire at day 7 and day 28 after intravitreal injection. Best-corrected VA measured by Snellen chart was recorded in logarithm of the minimum angle of resolution (logMAR) scale. OCT and tear sample collection was repeated at day 28. VEGF level of tear samples was measured using ELISA Kit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112474 0
Dr Supanji Haryanto
Address 112474 0
Gedung Rawat Jalan Lantai 5 SMF Ilmu Kesehatan Mata
RSUP Dr. Sardjito
Jalan Kesehatan No. 1 Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281
Country 112474 0
Indonesia
Phone 112474 0
+62274631190
Fax 112474 0
Email 112474 0
supanji@ugm.ac.id
Contact person for public queries
Name 112475 0
Supanji Haryanto
Address 112475 0
Gedung Rawat Jalan Lantai 5 SMF Ilmu Kesehatan Mata
RSUP Dr. Sardjito
Jalan Kesehatan No. 1 Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281
Country 112475 0
Indonesia
Phone 112475 0
+62274631190
Fax 112475 0
Email 112475 0
supanji@ugm.ac.id
Contact person for scientific queries
Name 112476 0
Supanji Haryanto
Address 112476 0
Gedung Rawat Jalan Lantai 5 SMF Ilmu Kesehatan Mata
RSUP Dr. Sardjito
Jalan Kesehatan No. 1 Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281
Country 112476 0
Indonesia
Phone 112476 0
+62274631190
Fax 112476 0
Email 112476 0
supanji@ugm.ac.id

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12443Ethical approval    382354-(Uploaded-06-07-2021-14-01-21)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
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