NCT01737957

Brief Summary

To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

November 23, 2012

Last Update Submit

May 29, 2024

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic retinopathyPan-retinal photocoagulation

Outcome Measures

Primary Outcomes (1)

  • Macular thickness change

    Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)

    Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

Secondary Outcomes (1)

  • Adverse events

    16 weeks

Other Outcomes (1)

  • Regression of neovessels, change over time

    Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

Study Arms (2)

Low-fluence

EXPERIMENTAL

Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy

Device: Low-fluence PRP with 532nm green LASER

Full-fluence

ACTIVE COMPARATOR

Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy

Device: Full-Fluence PRP with 532nm LASER

Interventions

Low-fluence PRP with 532nm green LASERDEVICE

To administer low-fluence PRP in a single session for PDR

Also known as: PURE-POINT LASER
Low-fluence
Full-Fluence PRP with 532nm LASERDEVICE

To administer full-fluence PRP in two sessions for PDR

Also known as: PURE-POINT LASER
Full-fluence

Eligibility Criteria

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

You may qualify if:

  • Type 1 or type 2 diabetics
  • Proliferative diabetic retinopathy

You may not qualify if:

  • Previous treatment with PRP
  • Media opacities
  • Previous treatment for macular edema (LASER or intravitreal injections)
  • Recent (less than 6 months) ophthalmic surgery
  • Only eyes
  • Intra-retinal or sub-retinal fluid with foveal involvement
  • Chronic renal failure
  • History of liver or pancreatic transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Para Evitar la Ceguera en México

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Guillermo Salcedo-Villanueva, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2012

First Posted

November 30, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)