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Diabetic Macular EdemaEarly Phase 1NCT06205979

Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents

A Early Phase 1 study testing Ranibizumab Injection [Lucentis] and Aflibercept Injection [Eylea] in people with Diabetic Macular Edema, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetic retinopathy (DR) is considered the main etiology of blindness among working-age adults, and Diabetic macular edema (DME) is the main reason for vision loss related to DR . Retinal oedema is responsible for retinal micro-structural alterations, retinal atrophy of photoreceptors and ganglion cell disorders . Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Ranibizumab Injection [Lucentis] and Aflibercept Injection [Eylea]
Type of treatment
Injection or infusion
How many people
50 participants
Where
1 siteEgypt
Study dates
12 Dec 2023to 14 Jun 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with type II DM and center involving DME with central foveal thickness more than 280 um.

Who cannot join

  • Evidence of macular ischemia
  • Evidence of macular traction
  • Previous intravitreal injections
  • Previous macular laser therapy
  • Previous pars plana vitrectomy

Trial locations and contacts

1 site in 1 country.

Ola G Ameen, resident contact

01009507654

ola011117@med.sohag.edu.eg

. Khulood M Mahmood, professor contact

01001173960

Egypt1 site, 1 recruiting

  • Sohag university Hospital

    Sohag

    Magdy M Amin, professor

    Recruiting

Other trials in Egypt

About this study

Diabetic retinopathy (DR) is considered the main etiology of blindness among working-age adults, and Diabetic macular edema (DME) is the main reason for vision loss related to DR . Retinal oedema is responsible for retinal micro-structural alterations, retinal atrophy of photoreceptors and ganglion cell disorders . In addition, it might be considered consensual that the best improvements in VA could be accomplished when retinal oedema is managed. In the context of a chronic and progressive disease, DME has to be faced as a state to control as effectively and rapidly as possible . Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels. It also makes the blood vessels more leaky. Anti- VEGF medicines stop the growth of these new blood vessels. This prevents damage to the retinal light receptors and loss of central vision. The DME treatment has been shifted from the laser photocoagulation to anti-VEGF therapy . The advantages of anti-VEGF therapy in decreasing DME and improving patient's vision have been reported in many studies . Ranibizumab, in addition to aflibercept, have been reported as the first line therapies among the other anti-VEGF . There are several data demonstrating the efficiency of ranibizumab in treatment of patients with DME . On the other hand, there are studies that revealed poor response of some patients to anti-VEGF therapies even after 3 or more injections Non-modifiable risk factors for diabetic retinopathy are gender and DM duration.

Modifiable risk factors contributing to the development of diabetic retinopathy are elevated blood sugar levels, blood pressure, and dyslipidemia which is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density lipoprotein (HDL). This condition can result from diet, tobacco exposure, or genetic . Hard exudates are thought to be induced by the leakage of lipids from dysfunctional retinal capillaries . Therefore, theses were formulated that higher levels of total cholesterol, LDL-C and triglycerides could be considered biomarkers of the development of hard exudates in DM patients . Aim of the work

  • Correlate between dyslipidemia and the response of patients with diabetic macular oedema to intravitreal anti-VEGF injection
Being tested
Ranibizumab Injection [Lucentis], Aflibercept Injection [Eylea]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ranibizumab Injection [Lucentis]Drug

    Three consecutive monthly intravitreal injections of Ranibizumab at a dosage of 0.5mg/0.05ml were administered in a sterile manner using a 30-G needle toward the center of the vitreous at 4mm in phakic or 3.5mm in pseudo phakic eyes from the limbus.

  • Aflibercept Injection [Eylea]Drug

    Three consecutive monthly intravitreal injections of Aflibercept at a dosage of 2mg/0.05ml were administered in a sterile manner using a 30-G needle toward the center of the vitreous at 4mm in phakic or 3.5mm in pseudo phakic eyes from the limbus.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in the best corrected visual acuity in meters

    measure of the ability of the eye to distinguish shapes and the details of objects at a given distance with the help of corrective lenses

    Measured: 2 months

  2. change in the retina and macula measurements by Optical coherence tomography (OCT)

    assess the state of the retina and macula by measuring :

    • Average Thickness in (μm)

    Measured: 2 months

  3. change in the retina and macula measurements by Optical coherence tomography (OCT)

    assess the state of the retina and macula by measuring :

    • Center thickness in (μm)

    Measured: 2 months

  4. change in the retina and macula measurements by Optical coherence tomography (OCT)

    assess the state of the retina and macula by measuring :

    • Total volume in (mm3)

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start12 Dec 2023
  3. Primary completion14 Jun 2024 (estimated)
  4. Study completion14 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06205979
Sponsor's protocol ID
Soh-Med-23-12-09MS
Status last verified
Jan 2024
First submitted
3 Jan 2024
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Abramoff MD, Lavin PT, Birch M, Shah N, Folk JC. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. NPJ Digit Med. 2018 Aug 28;1:39. doi: 10.1038/s41746-018-0040-6. eCollection 2018.

    PubMed 31304320

  • Bressler SB, Ayala AR, Bressler NM, Melia M, Qin H, Ferris FL 3rd, Flaxel CJ, Friedman SM, Glassman AR, Jampol LM, Rauser ME; Diabetic Retinopathy Clinical Research Network. Persistent Macular Thickening After Ranibizumab Treatment for Diabetic Macular Edema With Vision Impairment. JAMA Ophthalmol. 2016 Mar;134(3):278-85. doi: 10.1001/jamaophthalmol.2015.5346.

    PubMed 26746868

  • Ashraf M, Souka A, Adelman R. Predicting outcomes to anti-vascular endothelial growth factor (VEGF) therapy in diabetic macular oedema: a review of the literature. Br J Ophthalmol. 2016 Dec;100(12):1596-1604. doi: 10.1136/bjophthalmol-2016-308388. Epub 2016 May 26.

    PubMed 27231313

  • Katz G, Moisseiev E, Goldenberg D, Moisseiev J, Lomnicky Y, Abend Y, Treister G, Levkovitch-Verbin H. Ranibizumab for persistent diabetic macular edema after bevacizumab treatment. Eur J Ophthalmol. 2017 Mar 10;27(2):210-214. doi: 10.5301/ejo.5000838. Epub 2016 Jul 18.

    PubMed 27445070

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ranibizumab Injection [Lucentis] and Aflibercept Injection [Eylea] in people with Diabetic Macular Edema, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ola G Ameen, resident (01009507654, ola011117@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in the best corrected visual acuity in meters (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205979, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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