Effect and safety of the nutritional supplement Diamel Oral Solution® compared with placebo, in patients with diabetic macular edema without involvement of the macular center, treated or not with laser. Phase II

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

Diamel

Scientific title:

Effect and safety of the nutritional supplement Diamel Oral Solution® compared with placebo, in patients with diabetic macular edema without involvement of the macular center, treated or not with laser. Phase II

Secondary indentifying numbers:

CAT-2023-1

Issuing authority of the secondary identifying numbers:

National Coordinating Center for Clinical Trials

Source(s) of monetary or material support:

Catalysis Laboratories, SL.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

National Institute of Hygiene, Epidemiology and Microbiology (INHEM)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Juana

Midle name:

Elvira

Last name:

Maciques Rodriguez

Medical Specialty :

Second degree specialists in Ophthalmology

Affiliation:

National Institute of Endocrinology

Postal address:

Calle Zapata y D, Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78300465

Email address:

elviramr@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/08/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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

Diabetic Macular Edema

Intervention(s):

Diamel Group (Experimental): The Diamel will be administered one vial (30 ml) ® oral solution once a day, in the morning, for 12 months. Placebo Group (Experimental): The placebo will be administered in the same way and with the same frequency and duration as Diamel. Two strata of patients are considered, one for patients who will not require laser treatment and another for patients with criteria for laser treatment. In each stratum patients will be assigned to one of the two treatment groups

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Macular thickness (It is measured in microns. It will be evaluated taking into account the response categories Satisfactory (50% decrease with respect to the baseline value), Unsatisfactory (Decrease less than 50% with respect to the baseline value or no decrease or increase in thickness macular)). Measurement time: At baseline and, 12 months

Key secondary outcomes:

1. Visual acuity (It is measured in decimal units. The increase with respect to the baseline value will be evaluated. It will be considered satisfactory (Improvement of 0.2 tenths or more with respect to the baseline value) or unsatisfactory (Improvement of less than 0.2 tenths with respect to the baseline value, no improvement or worsening of visual acuity)). Measurement time: At baseline, at 6 months and 12 months 2. Glycemic control (It will be evaluated through the values that show the glycated hemoglobin (HbA1c) taking into account the following scale: good (if the values are less than 7.0%), acceptable (if the values are from 7.0 to 7.9%), or poor (if the values are equal to or greater than 8.0%)). Measurement time: At baseline, 3 months, 6 months, 9 months and 12 months 3. Metabolic control (Values of glycated hemoglobin, glycemia, cholesterol, triglycerides, creatinine and uric acid according to the units in which it is measured). Measurement time: At baseline, 3 months, 6 months, and 12 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

69 years

Inclusion criteria:

1. Type 1 or 2 diabetic patients with diabetic macular edema that does not affect the center of the macula, treated or not with laser. 2. Patients between the ages of 20 and 69 years. 3. Patients with glycosylated hemoglobin (HbA1c) < 9.0% at baseline. 4. Patients who voluntarily give their written informed consent.

Exclusion criteria:

1. Pregnant and/or breastfeeding patients. 2. Patients with diabetic macular edema affecting the center of the macula. 3. Patients with diabetic macular edema with vitreoretinal traction. 4. Patients with refractive media opacity that makes ophthalmologic examination difficult (example: patients with cataracts or less than one year after surgery). 5. Patients with a known history of hypersensitivity to another similar product or to one of the components of the test product formulation. 6. Patients undergoing treatment with any other nutritional supplement.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

160

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Arilia

Last Name:

Garcia Lopez

Specialty:

Bachelor's degree in Microbiology. Master in Experimental Toxicology

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

Calle 5taA e/ 60 y 62, Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164207

Email :

arilia@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ivis

Middle Name:

Cristina

Last Name:

Mendoza Hernandez

Specialty:

Bachelor's degree in Pharmaceutical Sciences. Master in Clinical Pharmacology and, Master in Clinical Trials

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

Calle 5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

Email :

ivis@cencec.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Institute of Endocrinology

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/06/2024

Postal address of Ethic Committee :

Calle Zapata y D, Vedado, Havana, ZC: 10400, Cuba

Telephone:

+53-78327275

Correo electrónico:

yanetra@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

16/08/2026

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000447

Date of Registration in Primary Registry:

31/07/2024

Record Verification Date:

2024/07/31

Next update date:

2025/07/31

Link to the spanish version:

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Proceso de Registro

Effect and safety of the nutritional supplement Diamel Oral Solution® compared with placebo, in patients with diabetic macular edema without involvement of the macular center, treated or not with laser. Phase II

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