Proliferative Diabetic Retinopathy (PDR)PRP VS PRP&RZBNCT07819253
Laser Photocoagulation and Ranibizumab Treatment in Proliferative Diabetic Retinopathy
A study testing Ranibizumab 0.5 mg and laser photocoagulation (PRP) in people with Proliferative Diabetic Retinopathy (PDR), run by Aswan University at 1 site in Egypt.
Trial summary
To evaluate the effects of PRP as monotherapy or with combination of intravitreal Ranibizumab injection on microvascular density changes of the macula of eyes with PDR using OCTA Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy (PDR)
- What is being tested?
- Ranibizumab 0.5 mg and laser photocoagulation (PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 31 Jul 2025
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- PDR patients diagnosed clinically and by the presence of neovascularization on optic disc (NVDs) or elsewhere (NVEs) on fluorescein angiography.
Who cannot join
- a) History of previous intra ocular surgery, uveitis, glaucoma and significant eye trauma.
- Significant media opacity decreasing image quality (corneal opacity, dense cataract, and vitreous hemorrhage)
- Significant macular edema to overcome errors in segmentation
- Scans with low signal strength index (SSI; < 50), presence of blink artifacts, and poor fixation leading to motion artifacts.
- History of previous treatment for diabetic retinopathy including intravitreal injection of anti-VEGFs, laser, or vitrectomy
- Presence of vitreo-macular traction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pan-Retinal Photocoagulation With Intravitreal Ranibizumab In Treatment Of Proliferative Diabetic Retinopathy
To evaluate the effects of PRP as monotherapy or with combination of intravitreal Ranibizumab injection on microvascular density changes of the macula of eyes with PDR using OCTA
Read the detailed description
The global prevalence of diabetes mellitus (DM) in 2019 is estimated to be 9.3% (463 million people). Diabetic retinopathy represents the fifth cause of blindness globally and the commonest visual impairing condition in working-age people.
Diabetic retinopathy (DR) is microangiopathy characterized by capillary non-perfusion, microaneurysms (MAs), and retinal ischemia. It may cause many complications, such as diabetic macular edema (DME) and diabetic macular ischemia (DMI).
Capillary ischemia decreases the nutrition of the retina and causes of hypoxia which results in increased level vascular endothelial growth factor (VEGF), which promotes angiogenic responses causing both neovascularization (proliferative diabetic retinopathy, PDR) and vascular permeability (macular edema).
Pan-retinal photocoagulation (PRP) is the standard treatment for proliferative diabetic retinopathy (PDR). It improves oxygenation of the ischemic retina. Destruction of the highly active photoreceptor cells is the suggested mechanism of action for PRP. Subsequently, production of VEGFs, the key player in neovascularization process, is reduced leading to regression of new vessels.
However, the use of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents as (Ranibizumab, Bevacizumab and Aflibercept) for the treatment of PDR has provided encouraging results in the last decade, with better functional outcomes compared to PRP.
Both treatments have a positive effect in delaying progression of DR, and they also have been combined many times in clinical practice. However the efficacy of monotherapy and combined treatment may be different. Many studies concluded that PRP and Anti VEGF treatment can achieve the ideal efficacy on DR by improving visual acuity and neovascularization regression.
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 theoretically increase blood flow in the macula and may reverse the ischemia flow.
While most previous studies have explored the large vessel effects of PRP, the development of optical 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 studies have demonstrated the competence of OCTA in the quantification of microvascular density, choroidal flow area, and foveal avascular zone (FAZ) area in diabetic patients.
Unlike other studies that focused only on the effect of PRP alone on macular vascular flow, our study will focus on the additional effect of intravitreal Anti-VEGF (Ranibizumab) with PRP on the macula of eyes with PDR using OCTA.
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Being tested
- Ranibizumab 0.5 mg, laser photocoagulation (PRP)
- Keywords
- diabetic retinopathy, Ranibizumab, laser, Photocoagulation
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5 mgDrug
Groupe (1) included eyes that underwent laser photocoagulation (PRP) in two sessions 1week apart, and group (2), included eyes that were treated with laser photocoagulation (PRP) combined with intravitreal anti VEGF (ranibizumab 0.5 mg) injection one week before PRP, which was also performed in two sessions 1 week apart
laser photocoagulation (PRP)Procedure or surgery
photocoagulation was performed through a contact lens (Ocular Mainster PRP 165, Ocular Instruments, Bellevue, WA, USA) using double frequency YAG, 532 nm (Ellex Medical Pty Ltd. 3-4 Second Ave, Mawson Lakes SA 5095, Australia) with a 200-µm spot diameter and a 100 m-s pulse duration. The power of the laser was individually adjusted to produce yellowish-white coagulative spots. PRP was performed by a single retina specialist in 2 sessions with an interval of 1 week in-between with a total number of 1500-3000 burns
| Study group | Role | What they receive |
|---|---|---|
| Pan-retinal photocoagulation group | Other | Included eyes that underwent laser treatment (PRP) only in two sessions 1week apart Receives: Procedure: laser photocoagulation (PRP) |
| Combined Pan-retinal photocoagulation and Ranibizumab Group | Active comparator | Included eyes that were treated with PRP combined with intravitreal anti VEGF (ranibizumab 0.5 mg) injection one week before PRP, which was also performed in two sessions 1 week apart Receives: Drug: Ranibizumab 0.5 mg; Procedure: laser photocoagulation (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular vessel density changes
Macular vessel density changes including ( superficial capillary plexus density, deep capillary plexus density and Foveal Avascular zone) using optical coherence tomography angiography
Measured: one month and three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Jul 2023
- Primary completion1 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic Retinopathy (PDR)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I treated with laser (PRP) only and Group II treated with combined laser (PRP) and intravitreal Ranibizumab
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Moussa Mohamed, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819253
- Sponsor's protocol ID
- 804/6/23
- Acronym
- PRP VS PRP&RZB
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-Retinal Photocoagulation With Intravitreal Ranibizumab In Treatment Of Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT07819253
- Acronym / sponsor ID
- PRP VS PRP&RZB / 804/6/23
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Keywords
- diabetic retinopathy, Ranibizumab, laser, Photocoagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 Sep 2026 (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.
To evaluate the effects of PRP as monotherapy or with combination of intravitreal Ranibizumab injection on microvascular density changes of the macula of eyes with PDR using OCTA
Detailed description
The global prevalence of diabetes mellitus (DM) in 2019 is estimated to be 9.3% (463 million people). Diabetic retinopathy represents the fifth cause of blindness globally and the commonest visual impairing condition in working-age people.
Diabetic retinopathy (DR) is microangiopathy characterized by capillary non-perfusion, microaneurysms (MAs), and retinal ischemia. It may cause many complications, such as diabetic macular edema (DME) and diabetic macular ischemia (DMI).
Capillary ischemia decreases the nutrition of the retina and causes of hypoxia which results in increased level vascular endothelial growth factor (VEGF), which promotes angiogenic responses causing both neovascularization (proliferative diabetic retinopathy, PDR) and vascular permeability (macular edema).
Pan-retinal photocoagulation (PRP) is the standard treatment for proliferative diabetic retinopathy (PDR). It improves oxygenation of the ischemic retina. Destruction of the highly active photoreceptor cells is the suggested mechanism of action for PRP. Subsequently, production of VEGFs, the key player in neovascularization process, is reduced leading to regression of new vessels.
However, the use of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents as (Ranibizumab, Bevacizumab and Aflibercept) for the treatment of PDR has provided encouraging results in the last decade, with better functional outcomes compared to PRP.
Both treatments have a positive effect in delaying progression of DR, and they also have been combined many times in clinical practice. However the efficacy of monotherapy and combined treatment may be different. Many studies concluded that PRP and Anti VEGF treatment can achieve the ideal efficacy on DR by improving visual acuity and neovascularization regression.
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 theoretically increase blood flow in the macula and may reverse the ischemia flow.
While most previous studies have explored the large vessel effects of PRP, the development of optical 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 studies have demonstrated the competence of OCTA in the quantification of microvascular density, choroidal flow area, and foveal avascular zone (FAZ) area in diabetic patients.
Unlike other studies that focused only on the effect of PRP alone on macular vascular flow, our study will focus on the additional effect of intravitreal Anti-VEGF (Ranibizumab) with PRP on the macula of eyes with PDR using OCTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group I treated with laser (PRP) only and Group II treated with combined laser (PRP) and intravitreal Ranibizumab
| Arm | Type | Receives |
|---|---|---|
| Pan-retinal photocoagulation group | Other | Procedure: laser photocoagulation (PRP)Included eyes that underwent laser treatment (PRP) only in two sessions 1week apart |
| Combined Pan-retinal photocoagulation and Ranibizumab Group | Active comparator | Drug: Ranibizumab 0.5 mg, Procedure: laser photocoagulation (PRP)Included eyes that were treated with PRP combined with intravitreal anti VEGF (ranibizumab 0.5 mg) injection one week before PRP, which was also performed in two sessions 1 week apart |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PDR patients diagnosed clinically and by the presence of neovascularization on optic disc (NVDs) or elsewhere (NVEs) on fluorescein angiography.
Key exclusion criteria (6 listed)
- a) History of previous intra ocular surgery, uveitis, glaucoma and significant eye trauma.
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 |
|---|---|---|
| Ranibizumab 0.5 mgGroupe (1) included eyes that underwent laser photocoagulation (PRP) in two sessions 1week apart, and group (2), included eyes that were treated with laser photocoagulation (PRP) combined with intravitreal anti VEGF (ranibizumab 0.5 mg) injection one week before PRP, which was also performed in two sessions 1 week apart | Drug | Combined Pan-retinal photocoagulation and Ranibizumab Group |
| laser photocoagulation (PRP)photocoagulation was performed through a contact lens (Ocular Mainster PRP 165, Ocular Instruments, Bellevue, WA, USA) using double frequency YAG, 532 nm (Ellex Medical Pty Ltd. 3-4 Second Ave, Mawson Lakes SA 5095, Australia) with a 200-µm spot diameter and a 100 m-s pulse duration. The power of the laser was individually adjusted to produce yellowish-white coagulative spots. PRP was performed by a single retina specialist in 2 sessions with an interval of 1 week in-between with a total number of 1500-3000 burns | Procedure or surgery | Combined Pan-retinal photocoagulation and Ranibizumab Group, Pan-retinal photocoagulation group |
Primary outcome
macular vessel density changes
Time frame: one month and three months after treatment
Macular vessel density changes including ( superficial capillary plexus density, deep capillary plexus density and Foveal Avascular zone) using optical coherence tomography angiography
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab 0.5 mg and laser photocoagulation (PRP) in people with Proliferative Diabetic Retinopathy (PDR), run by Aswan 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 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 15 Sep 2026. 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?
macular vessel density changes (time frame: one month and three months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.