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Status unknownNCT04800679Updated Mar 16, 2021

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

A Phase 2 interventional study of receive 4 monthly IVB injections and then rescue IVB and PRP group in Proliferative Diabetic Retinopathy, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Proliferative Diabetic Retinopathy

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03

In context

Diabetic Retinopathy

773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.

This study's planned enrollment of 105 is above the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
105 participants (estimated)

Study arms

  • Active comparator
    intravitreal bevacizumab injections and then rescue

    Drug: receive 4 monthly IVB injections and then rescue IVB

  • Active comparator
    PRP group

    Drug: PRP group

  • Active comparator
    IVB injections and a modified laser

    Drug: IVB injections and a modified laser

Interventions

  • Drugreceive 4 monthly IVB injections and then rescue IVB

    IVB group that receive 4 monthly IVB injections and then rescue IVB

  • DrugPRP group

    PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB

  • DrugIVB 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. Best corrected visual acuity based on Snellen chart

    Time frame: 12 months

  2. Central retinal thickness according to macular OCT

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • Ophthalmic Research Center
    Tehran, Iran, Islamic Republic of
    Recruiting
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References and documents

Publications

  • Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450. PubMed 35594075 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04800679
Lead sponsor
Shahid Beheshti University of Medical Sciences
Responsible party
Zahra Rabbani Khah (Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
Mar 16, 2021
Start date
Mar 1, 2020
Primary completion
Jul 1, 2020
Completion
Dec 2021 (estimated)
Last update
Mar 16, 2021

Study contacts

Alireza Ramezani, MD
Contact
labbafi@hotmail.com
009822591616

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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