Protocol summary

Study aim
A comparative study of the synergistic effect of the combination of curcumin and piperine as an adjuvant treatment and bevacizumab injection as a common treatment in patients with age-related macular degeneration of the neovascular type.
Design
After approving the plan and obtaining necessary permits, 60 patients were selected and randomly divided into two groups, case and control. Randomization is one of the important principles in the design and implementation of this plan. By using this method, the possibility of disturbance in the variable factors affecting the test results is reduced and better confidence is obtained in the interpretation of the results. In this clinical trial design with 30 control and 30 intervention people, the randomization method is used to randomly distribute people into two different groups. After selecting the subjects, the researcher first explained the objectives of the study to them in a simple and understandable language, and then provided them with an informed consent form to sign after careful study.
Settings and conduct
This plan will be carried out in Al-Zahra Ophthalmology Hospital under Zahedan University of Medical Sciences. In such a way that the case group will be given real capsules and the control group will be given placebo capsules.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: • Signed written informed consent • Aged 45 - 80 years, male or female • Diagnosed with neovascular AMD and with active lesions. Exclusion Criteria: • Any history of allergy or sensitivity to turmeric, pepper, curcumin or piperine • Any history of allergy or sensitivity to antiVGEFs •
Intervention groups
The intervention groups will be given a combination of curcumin and peprine along with the common drug bevacizumab
Main outcome variables
Macular thickness; macular fluid; density of vessel in OCTA; Best Corrected Visual Aquity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230614058480N1
Registration date: 2023-09-19, 1402/06/28
Registration timing: registered_while_recruiting

Last update: 2023-09-19, 1402/06/28
Update count: 0
Registration date
2023-09-19, 1402/06/28
Registrant information
Name
Alireza Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3337 2151
Email address
reza.ghoreishi1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the synergistic effect of Combination of curcumin and piperine supplementation as an adjuvant treatment to the usual treatment method using Bevacizumab in patients with neovascular age-related macular degeneration
Public title
Synergistic effect of Combination of curcumin and piperine supplementation as an adjuvant treatment to the usual treatment method using Bevacizumab in patients with neovascular age-related macular degeneration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signed written informed consent Age 45 - 80 years, male or female Neovascular AMD is diagnosed with active lesions
Exclusion criteria:
Any history of allergy or sensitivity to turmeric, pepper, curcumin or piperine Any history of allergy or sensitivity to antiVGEFs With vitreous hemorrhage in the studied eyes With geographic atrophy, epiretinal membrane or hard subfoveal exudates involving the foveal in the studied eyes With opacification of the refractive medium (such as apparent cataract) or pupillary constriction that significantly interferes with vision testing or evaluation of the anterior segment and fundus in the study eyes. With rhegmatogenous retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause other than AMD (eg, fundus angioid streaks, ocular histoplasmosis, pathologic myopia, trauma) in study eyes. With apparent afferent pupillary defect (RAPD) in the studied eyes With polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (PAP) in the studied eyes With intraocular pressure above 25 mmHg despite treatment With active inflammation in each eye, such as conjunctivitis, keratitis, scleritis, blepharitis, endophthalmitis, and uveitis. The study eye received topical or retinal photocoagulation more than twice or within 3 months before screening. The study eye received the following intraocular surgery or laser therapy in the macula (eg, macular displacement surgery, glaucoma filter surgery, transpupillary thermotherapy, macular photocoagulation, vitreous incision surgery, optic nerve dissection, optic nerve sheath membrane dissection). However, patients who received vertporfin photodynamic therapy, cataract surgery, or YAG posterior capsular dissection more than 3 months prior to screening will not be excluded. Any eye received antiangiogenic drugs in the 2 months before screening or patients who received systemic antiangiogenic drugs in the 3 months before screening (eg, pegaptanib, aflibercept, ranibizumab, bevacizumab, or canbercept). Any eye had received an intraocular injection of a corticosteroid (eg, triamcinolone acetonide) within 3 months prior to screening, or had received an ophthalmic injection of a corticosteroid within 1 month prior to screening for systemic disease, treatment, or other conditions. With a history of sensitivity to sodium fluorescein and indocyanine green PLT≤100×109/L, BUN or Cr>1.5×ULN (upper limit of normal), TT (thrombin time) or PT (prothrombin time) >1.0×ULN (upper limit of normal), take antiplatelet. Medications or anticoagulants 1 month before screening With surgery one month before screening, or with a current unhealed wound, ulcer, or fracture Diabetic patients without glucose control or with diabetic retinopathy With a history of myocardial infarction in the 6 months before screening With intravascular coagulation activity and significant bleeding tendency before screening Systemic autoimmune disease Any uncontrolled disease (such as severe systemic mental, neurological, cardiovascular, respiratory, and malignancies) Pregnant and lactating women or patients who cannot take contraceptive measures Poor compliance Patients who participated in or were currently participating in other clinical trials within 30 days prior to screening. Patients deemed unsuitable for enrollment by the investigator
Age
From 45 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, we use a table of random numbers and place each client in the intervention or control group. One of the advantages of this type of randomization is that the type of treatment assigned to the two groups is completely unpredictable
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Zahedan University of Medical Sciences
Street address
Mottahari blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.ZAUMS.REC.1402.138

Health conditions studied

1

Description of health condition studied
Age Related Macular Degeneration
ICD-10 code
H35.3
ICD-10 code description
Degeneration of macula and posterior pole

Primary outcomes

1

Description
Central Sub-Field Retinal Thickness (CSFT)
Timepoint
0,1 month, 2 and 3 months after intervention
Method of measurement
Objective measurement of macular thickness (from OCT findings)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with neovascular AMD and diagnosed with active lesions. Capsules containing curcumin 1000mg with 10mg of piperine will be provided by Biotechnology Research Center, Mashhad University of Medical Sciences. Standard Treatment intervention groups will receive standard treatment of monthly 1.25 mg of intravitreal Bevacizumab Duration of intervention 3 months
Category
Treatment - Drugs

2

Description
Control group: patients with neovascular AMD and diagnosed with active lesions.placebo Capsules will be provided by Biotechnology Research Center, Mashhad University of Medical Sciences.Standard Treatment intervention groups will receive standard treatment of monthly 1.25 mg of intravitreal Bevacizumab Duration of intervention3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Eye Hospital of Zahedan
Full name of responsible person
Alireza Maleki
Street address
Motahari blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3778998167
Phone
+98 54 3321 9915
Email
reza.ghoreishi1373@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshani
Street address
Alzahra ophthalmology hospital, Khalij-e-fars blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 4395
Email
reza.ghoreishi1373@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Maleki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Motahhari blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743483
Phone
+98 54 3329 4395
Email
baaardiyax@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Maleki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Alzahra ophthalmology hospital, Motahhari Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Fax
Email
baaardiyax@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Maleki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Alzahra ophthalmology hospital, Motahhari Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Fax
Email
baaardiyax@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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