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Compares treatment options for Proliferative Diabetic Retinopathy (PDR)
Official title Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
ClinicalTrials.gov ID: NCT07586787
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn whether early microincision vitrectomy surgery (MIVS) can improve retinal neovascularization outcomes compared to standard pan-retinal photocoagulation (PRP) in patients with early proliferative diabetic retinopathy (PDR). It will also evaluate the safety and functional outcomes of early surgical intervention in this population.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus.
- Presence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does...
- Relatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal photocoagulation and retinal imaging.
- Ability and willingness to provide written informed consent.
You likely can't join if
- Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye.
- Retinal traction or retinal detachment.
- Optic neuropathy.
- Macular edema caused by reasons other than diabetes.
- Coexisting ocular disease that may decrease visual acuity during the study.
- Substantial cataract likely to decrease visual acuity by more than three lines.
See the full eligibility criteria
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus.
- Presence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does not interfere with evaluation of neovascularization.
- Relatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal photocoagulation and retinal imaging.
- Ability and willingness to provide written informed consent.
- If both eyes are eligible, the eye with worse vision will be included.
- Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye.
- Retinal traction or retinal detachment.
- Optic neuropathy.
- Macular edema caused by reasons other than diabetes.
- Coexisting ocular disease that may decrease visual acuity during the study.
- Substantial cataract likely to decrease visual acuity by more than three lines.
- Major ocular surgery within the past 4 months or planned intraocular surgery within the next 6 months.
- YAG capsulotomy within the past 2 months.
- Any intravitreal injection within the past 3 months.
- Aphakia.
- Severe external ocular infection.
- Uncontrolled glaucoma.
- Significant renal disease requiring dialysis or kidney transplantation.
- Unstable glycemic control.
- Blood pressure greater than 180/110 mmHg.
- History of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac event requiring hospitalization within the past 4 months.
- Pregnant, lactating, or intending to become pregnant during the study period.
- Participation in another clinical trial.
- Unwilling or unable to provide informed consent, undergo randomization, or return for scheduled visits.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Dalian, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Zhengzhou, Henan, China; Nanjing, Jiangsu, China; Dalian, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.