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Study to compare efficacy of intravitreal injection (ranibizumab) plus laser vs only laser in proliferative diabetic retinopathy

Panretinal photocoagulation vs panretinal photocoagulation with single injection of intravitreal anti-vascular endothelial growth factor for the treatment of proliferative diabetic retinopathy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093218
Enrollment
114
Registered
2025-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

Intervention1: Intravitreal Ranibizumab: Single injection of intravitreal Ranibizumab (0.5mg/0.05ml)followed by Panretinal photocoagulation (PRP)after 1 week. Total 3 weekly sittings of PRP will be gi

Sponsors

Dr Astha Kansal
Lead Sponsor
Dr Shreyas Temkar S
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Individuals with diabetes (type 1 or type 2) 2. Age more than or equal to 18 years 3. Proliferative diabetic retinopathy which the treating physician intends to manage with PRP . 4. Media clarity, pupillary dilation, and individual cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT

Exclusion criteria

Exclusion criteria: Ocular exclusion criteria 1. History of prior PRP 2. Centre involving diabetic macular edema (central subfield thickness of more than or equal to 290?m in women, 305?m in men) (OCT shall be done on Zeiss Cirrus 500) 3. History of receiving intravitreal anti-VEGF or steroid injections in the previous 4 months 4. Macular tractional retinal detachment 5. Presence of vitreous haemorrhage dense enough to preclude successful completion of PRP (as per decision of treating physician) 6. History of prior vitrectomy surgery Systemic exclusion criteria 1. Poor diabetes control (HbA1C more than 12 percent) 2. Poor systemic condition (end stage renal disease on dialysis or other diseases which the treating physician feels can have a significant contribution to the progression of diabetic retinopathy) 3. Inability to follow up at regular intervals

Design outcomes

Primary

MeasureTime frame
1. Patterns of regression of retinal neovascularization 2. Completeness of PRP and the need for additional laser 3. Central subfield thickness 4. Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranesTimepoint: 6 weeks, 3 months, 6 months post last PRP session

Secondary

MeasureTime frame
Completeness of PRP and the need for additional laserTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Central subfield thicknessTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranesTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Visual acuity differencesTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Need for PPVTimepoint: 6 weeks, 3 months, 6 months post last PRP session

Countries

India

Contacts

Public ContactSHREYAS S TEMKAR

JIPMER

shreyastemkar@gmail.com09353370342

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026