NCT04800679

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 16, 2021

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 28, 2019

Last Update Submit

March 13, 2021

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

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

    12 months

Secondary Outcomes (2)

  • Best corrected visual acuity based on Snellen chart

    12 months

  • Central retinal thickness according to macular OCT

    12 months

Study Arms (3)

intravitreal bevacizumab injections and then rescue

ACTIVE COMPARATOR
Drug: receive 4 monthly IVB injections and then rescue IVB

PRP group

ACTIVE COMPARATOR
Drug: PRP group

IVB injections and a modified laser

ACTIVE COMPARATOR
Drug: IVB injections and a modified laser

Interventions

receive 4 monthly IVB injections and then rescue IVBDRUG

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

intravitreal bevacizumab injections and then rescue
PRP groupDRUG

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

PRP group
IVB injections and a modified laserDRUG

Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser

IVB injections and a modified laser

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35594075DERIVED

Central Study Contacts

Alireza Ramezani, MD

CONTACT

009822591616labbafi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of ophthalmic research center

Study Record Dates

First Submitted

December 28, 2019

First Posted

March 16, 2021

Study Start

March 1, 2020

Primary Completion

July 1, 2020

Study Completion

December 1, 2021

Last Updated

March 16, 2021

Record last verified: 2020-12

Locations

IR(1)