Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Combination Therapy for PDR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800679
• Other study ID #: 97378
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Alireza Ramezani, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Presence of PDR with the indication of full PRP according the intend of investigator

• Best corrected visual acuity of 20/320 or better

• Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT

Exclusion Criteria:

• History of prior PRP with more than 100 burns outside the posterior pole

• Tractional retinal detachment involving the macula

• Evidence of neoplasia of angle on examination

• Macular edema due to a cause other than DME

• Any ocular condition which may change visual acuity during the study

• Substantial cataract which has declined the vision by 3 lines or more

• History of intravitreal injection of anti-VEGF agent in past 2 months

• History of any use of corticosteroid during past 4 months

• History of major intra-ocular surgery except cataract surgery

• History of YAG laser capsulotomy during past 2 months

• Aphakia and uncontrolled glaucoma according to investigator judgment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy

Intervention

Drug:
• receive 4 monthly IVB injections and then rescue IVB
IVB group that receive 4 monthly IVB injections and then rescue IVB
• PRP group
PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
• IVB injections and a modified laser
Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG	Number of neovascular tissue counted by investigator according to FAG	12 months
Secondary	Best corrected visual acuity based on Snellen chart		12 months
Secondary	Central retinal thickness according to macular OCT		12 months