An interventional study of Ranibizumab 0.5 mg and laser photocoagulation (PRP) in Proliferative Diabetic Retinopathy (PDR), sponsored by Aswan University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Aswan University · Not applicable, Interventional, and Treatment
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Among 34 studies testing ranibizumab in Diabetic Retinopathy — 2 open to participants now, 2 under way, 1 of them phase 3. Ranibizumab · Diabetic Retinopathy.
Among the 34 studies testing ranibizumab in Diabetic Retinopathy, this one is the 14th largest by enrollment, is the only one that started in 2023, is one of 2 with no phase, and was the 34th registered.
779 studies on the registry are indexed under Diabetic Retinopathy; 143 are open to participants now.
Browse Diabetic Retinopathy studies →2 of the 34 studies testing ranibizumab in Diabetic Retinopathy are open now, in 2 countries. Recruiting first, the newest first:
Affiliated Hospital of Nantong University · Sites in China
Ages 18–80
Southeast Retina Center, Georgia · Sites in United States
Ages 18+
By country, each count listing its studies:
Ranibizumab: first FDA approval 2006 (LUCENTIS), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 92 Diabetic Retinopathy studies recruiting now, 60 (65%) set no upper age limit and 10 (11%) stop at 75 or younger; 8 take children under 18; 29 take healthy volunteers.
This study: 30 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 12 · Phase 3 9 · Phase 4 10
First in 2006; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is close to the median of 80 across 482 interventional studies indexed under Diabetic Retinopathy.
Median enrollment 57 across the 34 interventional studies. Of the 23 that completed or were terminated, 9 (39%) have results posted.
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9 of 34 have an industry lead sponsor. The 10 most frequent:
Aswan University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.
Aswan University has 1 study filed under Diabetic Retinopathy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 34 studies testing ranibizumab in Diabetic Retinopathy, from their registry updates:
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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
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.
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Exclusion Criteria:
a) History of previous intra ocular surgery, uveitis, glaucoma and significant eye trauma.
b) Significant media opacity decreasing image quality (corneal opacity, dense cataract, and vitreous hemorrhage)
c) Significant macular edema to overcome errors in segmentation
d) Scans with low signal strength index (SSI; \< 50), presence of blink artifacts, and poor fixation leading to motion artifacts.
e) History of previous treatment for diabetic retinopathy including intravitreal injection of anti-VEGFs, laser, or vitrectomy
f) Presence of vitreo-macular traction
Included eyes that underwent laser treatment (PRP) only in two sessions 1week apart
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
Drug: Ranibizumab 0.5 mg · Procedure: laser photocoagulation (PRP)
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
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
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
Time frame: one month and three months after treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Jul 2025, 24 months.
Of 111 non-industry interventional studies with no phase under Diabetic Retinopathy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 24 months is below that.
Counting every sponsor, half of 126 studies reached it within 29 months; a quarter within 11 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ranibizumab
Aswan University