Clinical trial NCT06821633: Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
Official title: Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. From February 2025 to August 2026, 30 diabetic patients attending the Ophthalmology Department of Sichuan Provincial People's Hospital will be enrolled. Using a simple randomization method, one eye of each patient will be assigned to the intervention group, while the contralateral eye will serve as the control, resulting in 30 eyes in each group. The intervention group will undergo OCTA-guided selective photocoagulation, specifically using a grid pattern (3x3) of spot laser applied once to the NP area, extending one spot diameter beyond the NP boundary. Each session will last 10-20 minutes. The control group will receive no treatment. The study will compare changes in NP area, DR grading progression, and control of other DR lesions at 3, 6, 9, and 12 months between the two groups.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Type 1 or Type 2 diabetes mellitus
* Clinical dilated fundus examination and Optos imaging within 7 fields showing diabetic retinopathy (DR) lesions no more severe than severe non-proliferative diabetic retinopathy (NPDR)
* Optical coherence tomography angiography (OCTA) demonstrating non-perfusion (NP) areas greater than 1 disc diameter (PD) in both eyes
* Diabetic retinopathy in both eyes at the same stage, with the total NP area within the observed range of OCTA being comparable (difference less than 5 PD)
* Absence of other ocular diseases that could lead to the formation of retinal microaneurysms
* Absence of other ocular diseases that could lead to the formation of retinal non-perfusion areas
* No diabetic macular edema involving the fovea
* No history of retinal laser treatment
* No history of intravitreal injection therapy within the past 3 months
* No history of ocular surgery other than cataract surgery
* Ability to cooperate with all examinations and provide informed consent

Exclusion Criteria:

* Optical media opacity affecting OCTA imaging
* Patients with difficulties in cooperating with laser treatment
* Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases
* Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces
* Patients requiring early PRP (conditions include: combined DME, planned cataract surgery, pregnancy planning, early PDR, poor follow-up compliance, severe vision loss in the other eye, poor glycemic control, poor renal function, or type 1 diabetes)
* FFA showing NP greater than 10 PD within the ETDRS area or a total NP area greater than 75 PD, or an ischemia index greater than 35%

Primary outcomes:
measure: The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months
timeFrame: From enrollment to reexamination at 0,3,6,9, and 12 months
Secondary outcomes:
measure: The number of microaneurysms, intraretinal microvascular abnormalities (IRMA) in both groups of eyes at 0, 3, 6, 9, and 12 months
timeFrame: From enrollment to reexamination at 0,3,6,9, and 12 months
measure: The number of neovascularization (NV) in both groups of eyes at 0, 3, 6, 9, and 12 months
timeFrame: From enrollment to reexamination at 0,3,6,9, and 12 months
measure: Area of foveal avascular zone (FAZ) at 0, 3, 6, 9, and 12 months in two groups of eyes
timeFrame: From enrollment to reexamination at 0,3,6,9, and 12 months
measure: DR grading at 0, 3, 6, 9, and 12 months in two groups of eyes
timeFrame: From enrollment to reexamination at 0,3,6,9, and 12 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References: