PRPNCT04976361
Macular Vessels Density Before and After PRP in Patients With Proliferative Diabetic Retinopathy
A study testing PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany) in people with PRP, run by Minia University at 1 site in Egypt.
Trial summary
In this study, OCTA is used to study the vascular changes following PRP in patients with PDR; regarding vessels density at 1 month and 6 months follow up period and measure superficial, deep, and outer retina for fovea, para-fovea and whole image. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- PRP
- What is being tested?
- PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 May 2021
- Phase
- Interventional
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with type 2 diabetes with PDR
- treatment-naive PDR diabetic patients diagnosed clinically and by the presence of neovascularization on optic disc (NVDs) or elsewhere (NVEs) on fluorescein angiography.
Who cannot join
- Patients with significant media opacity decreasing image quality
- -. Eyes with significant macular edema
- patients with glaucoma, uveitis, previous intraocular surgery, and history of previous treatment for diabetic retinopathy including anti-VEGF and laser
- patients with low signal strength index (SSI; <50)
- presence of 1 or more blink artifacts
- poor fixation leading to motion artifacts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macular Vessels Density Before and After Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
In this study, OCTA is used to study the vascular changes following PRP in patients with PDR; regarding vessels density at 1 month and 6 months follow up period and measure superficial, deep, and outer retina for fovea, para-fovea and whole image.
Read the detailed description
The global prevalence of diabetes mellitus in 2019 is estimated to be 9.3% (463 million people).1 Diabetic retinopathy (DR) is microangiopathy characterized by capillary non- perfusion, microaneurysms (MAs), and retinal ischemia. 2It may cause many complications, such as diabetic macular edema (DME) and diabetic macular ischemia (DMI).3 Capillary ischemia decreases the nutrition of the retina and causes hypoxia which results in increased level of vascular endothelial growth factor (VEGF), which promotes angiogenic responses causing both neovascularization (proliferative diabetic retinopathy, PDR) and vascular permeability (macular edema).
Panretinal photocoagulation (PRP) by argon or diode laser is the standard treatment for proliferative diabetic retinopathy. It improves oxygenation to the ischemic retina. Destruction of the highly active photoreceptor cells is the suggested mechanism of action for PRP. Subsequently, production of vascular endothelial growth factor (VEGF), the key player in neovascularization process, is reduced leading to regression of new vessels.5
PDR eyes have an overall lower blood flow than normal or non-PDR eyes, parallel to the higher level of retinal ischemia and disease severity. With regression of these neovascular and shunt vessels following PRP, normalization of flow in the macula may reverse the ischemia and decrease the stimulus for new blood vessel formation. Closure of intraretinal microvascular abnormalities and neovascularization would theoretically increase overall resistance to flow and, combined with the constriction of the large vessel in response to increased oxygen in the inner retina, collectively decrease the overall blood flow.6 While most previous studies have explored the large vessel effects of PRP, the development of ocular coherence tomography angiography (OCTA) allowed the study of microvascular retinal changes in a detailed manner. It is a non-invasive modality that allows vascular mapping with high speed and quality and promotes visualization of vascular system in different retinal and choroidal levels. Several investigations have demonstrated the competence of OCTA in the quantification of microvascular density, choroidal flow area, and foveal avascular zone (FAZ) area in diabetic patients.
- Conditions
- PRP
- Being tested
- PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
- Keywords
- OCTA, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)Other
PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Patients with PDR | Experimental | PRP for each diabetic patient included in this study. Receives: Other: PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of vessel density
Measurement of vessel density at superficial, deep, and outer retina at base line, after 1 month, and after 6 months.
Measured: 6 months
Measurement of retinal thickness
central retinal thickness at base line, after 1 month, and after 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Mar 2019
- Primary completion1 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PRPStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Minia University
- Investigators
- Ahmed Shawkat, Prof Dr, Study director, Minia University HospitalMohamed Farouk, Prof Dr, Study director, Minia University HospitalMohamed Salah, Doctor, Principal investigator, Minia University HospitalAsmaa Anwar, Doctor, Study director, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976361
- Sponsor's protocol ID
- VD befor and after PRP
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657Adhi M, Brewer E, Waheed NK, Duker JS. Analysis of morphological features and vascular layers of choroid in diabetic retinopathy using spectral-domain optical coherence tomography. JAMA Ophthalmol. 2013 Oct;131(10):1267-74. doi: 10.1001/jamaophthalmol.2013.4321.
PubMed 23907153Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
PubMed 2866759Miwa Y, Murakami T, Suzuma K, Uji A, Yoshitake S, Fujimoto M, Yoshitake T, Tamura Y, Yoshimura N. Relationship between Functional and Structural Changes in Diabetic Vessels in Optical Coherence Tomography Angiography. Sci Rep. 2016 Jun 28;6:29064. doi: 10.1038/srep29064.
PubMed 27350562Savage HI, Hendrix JW, Peterson DC, Young H, Wilkinson CP. Differences in pulsatile ocular blood flow among three classifications of diabetic retinopathy. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4504-9. doi: 10.1167/iovs.04-0077.
PubMed 15557461Cuypers MH, Kasanardjo JS, Polak BC. Retinal blood flow changes in diabetic retinopathy measured with the Heidelberg scanning laser Doppler flowmeter. Graefes Arch Clin Exp Ophthalmol. 2000 Dec;238(12):935-41. doi: 10.1007/s004170000207.
PubMed 11196354Ghassemi F, Fadakar K, Bazvand F, Mirshahi R, Mohebbi M, Sabour S. The Quantitative Measurements of Vascular Density and Flow Areas of Macula Using Optical Coherence Tomography Angiography in Normal Volunteers. Ophthalmic Surg Lasers Imaging Retina. 2017 Jun 1;48(6):478-486. doi: 10.3928/23258160-20170601-06.
PubMed 28613354Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.
PubMed 26605370Abdelhalim AS, Abdelkader MFSO, Mahmoud MSE, Mohamed Mohamed AA. Macular vessel density before and after panretinal photocoagulation in patients with proliferative diabetic retinopathy. Int J Retina Vitreous. 2022 Mar 14;8(1):21. doi: 10.1186/s40942-022-00369-1.
PubMed 35287760
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Vessels Density Before and After Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04976361
- Acronym / sponsor ID
- VD befor and after PRP
- Conditions
- PRP
- Keywords
- OCTA, PRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, OCTA is used to study the vascular changes following PRP in patients with PDR; regarding vessels density at 1 month and 6 months follow up period and measure superficial, deep, and outer retina for fovea, para-fovea and whole image.
Detailed description
The global prevalence of diabetes mellitus in 2019 is estimated to be 9.3% (463 million people).1 Diabetic retinopathy (DR) is microangiopathy characterized by capillary non- perfusion, microaneurysms (MAs), and retinal ischemia. 2It may cause many complications, such as diabetic macular edema (DME) and diabetic macular ischemia (DMI).3 Capillary ischemia decreases the nutrition of the retina and causes hypoxia which results in increased level of vascular endothelial growth factor (VEGF), which promotes angiogenic responses causing both neovascularization (proliferative diabetic retinopathy, PDR) and vascular permeability (macular edema).
Panretinal photocoagulation (PRP) by argon or diode laser is the standard treatment for proliferative diabetic retinopathy. It improves oxygenation to the ischemic retina. Destruction of the highly active photoreceptor cells is the suggested mechanism of action for PRP. Subsequently, production of vascular endothelial growth factor (VEGF), the key player in neovascularization process, is reduced leading to regression of new vessels.5
PDR eyes have an overall lower blood flow than normal or non-PDR eyes, parallel to the higher level of retinal ischemia and disease severity. With regression of these neovascular and shunt vessels following PRP, normalization of flow in the macula may reverse the ischemia and decrease the stimulus for new blood vessel formation. Closure of intraretinal microvascular abnormalities and neovascularization would theoretically increase overall resistance to flow and, combined with the constriction of the large vessel in response to increased oxygen in the inner retina, collectively decrease the overall blood flow.6 While most previous studies have explored the large vessel effects of PRP, the development of ocular coherence tomography angiography (OCTA) allowed the study of microvascular retinal changes in a detailed manner. It is a non-invasive modality that allows vascular mapping with high speed and quality and promotes visualization of vascular system in different retinal and choroidal levels. Several investigations have demonstrated the competence of OCTA in the quantification of microvascular density, choroidal flow area, and foveal avascular zone (FAZ) area in diabetic patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Patients with PDR | Experimental | Other: PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)PRP for each diabetic patient included in this study. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with type 2 diabetes with PDR
- treatment-naive PDR diabetic patients diagnosed clinically and by the presence of neovascularization on optic disc (NVDs) or elsewhere (NVEs) on fluorescein angiography.
Key exclusion criteria (6 listed)
- Patients with significant media opacity decreasing image quality
- -. Eyes with significant macular edema
- patients with glaucoma, uveitis, previous intraocular surgery, and history of previous treatment for diabetic retinopathy including anti-VEGF and laser
- patients with low signal strength index (SSI; <50)
- presence of 1 or more blink artifacts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany) | Other | Diabetic Patients with PDR |
Primary outcome
Measurement of vessel density
Time frame: 6 months
Measurement of vessel density at superficial, deep, and outer retina at base line, after 1 month, and after 6 months.
Measurement of retinal thickness
Time frame: 6 months
central retinal thickness at base line, after 1 month, and after 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Background: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background: PubMed 23907153Adhi M, Brewer E, Waheed NK, Duker JS. Analysis of morphological features and vascular layers of choroid in diabetic retinopathy using spectral-domain optical coherence tomography. JAMA Ophthalmol. 2013 Oct;131(10):1267-74. doi: 10.1001/jamaophthalmol.2013.4321.
- Background: PubMed 2866759Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
- Background: PubMed 27350562Miwa Y, Murakami T, Suzuma K, Uji A, Yoshitake S, Fujimoto M, Yoshitake T, Tamura Y, Yoshimura N. Relationship between Functional and Structural Changes in Diabetic Vessels in Optical Coherence Tomography Angiography. Sci Rep. 2016 Jun 28;6:29064. doi: 10.1038/srep29064.
- Background: PubMed 15557461Savage HI, Hendrix JW, Peterson DC, Young H, Wilkinson CP. Differences in pulsatile ocular blood flow among three classifications of diabetic retinopathy. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4504-9. doi: 10.1167/iovs.04-0077.
- Background: PubMed 11196354Cuypers MH, Kasanardjo JS, Polak BC. Retinal blood flow changes in diabetic retinopathy measured with the Heidelberg scanning laser Doppler flowmeter. Graefes Arch Clin Exp Ophthalmol. 2000 Dec;238(12):935-41. doi: 10.1007/s004170000207.
- Background: PubMed 28613354Ghassemi F, Fadakar K, Bazvand F, Mirshahi R, Mohebbi M, Sabour S. The Quantitative Measurements of Vascular Density and Flow Areas of Macula Using Optical Coherence Tomography Angiography in Normal Volunteers. Ophthalmic Surg Lasers Imaging Retina. 2017 Jun 1;48(6):478-486. doi: 10.3928/23258160-20170601-06.
- Background: PubMed 26605370Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.
- Derived from this study: PubMed 35287760Abdelhalim AS, Abdelkader MFSO, Mahmoud MSE, Mohamed Mohamed AA. Macular vessel density before and after panretinal photocoagulation in patients with proliferative diabetic retinopathy. Int J Retina Vitreous. 2022 Mar 14;8(1):21. doi: 10.1186/s40942-022-00369-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Shawkat, Prof Dr study director
Minia University Hospital
Mohamed Farouk, Prof Dr study director
Minia University Hospital
Mohamed Salah, Doctor principal investigator
Minia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany) in people with PRP, run by Minia 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jul 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of vessel density (time frame: 6 months). The study lists 2 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 NCT04976361, which also lists 9 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 26 Jul 2021.