Trial Outcomes & Findings for Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD (NCT NCT02800356)

NCT ID: NCT02800356

Last Updated: 2025-03-20

Results Overview

Change in retinal sensitivity on customized microperimetry (treated area).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline, 4 weeks and 12 weeks
• Results posted on: 2025-03-20

Participant Flow

Participant milestones

Measure	Pseudodrusen Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD

Baseline characteristics by cohort

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Age, Continuous	78.4 Years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	20 participants n=5 Participants
Retinal sensitivity in the treated area	12.08 dB STANDARD_DEVIATION 4.65 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks and 12 weeks

Change in retinal sensitivity on customized microperimetry (treated area).

Outcome measures

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Retinal Sensitivity Baseline	12.08 dB Standard Deviation 4.65
Retinal Sensitivity 4 weeks	11.08 dB Standard Deviation 5.06
Retinal Sensitivity 12 weeks	11.45 dB Standard Deviation 5.70

SECONDARY outcome

Timeframe: Baseline, 4 weeks and 12 weeks

Change in mean Visual Acuity

Outcome measures

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Visual Acuity Baseline	0.14 LogMAR Standard Deviation 0.09
Visual Acuity 4 weeks	0.135 LogMAR Standard Deviation 0.10
Visual Acuity 12 weeks	0.115 LogMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: Baseline, 4 weeks and 12 weeks

The thickness of the outer nuclear layer in the treated area was measured using structural OCT

Outcome measures

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
The Thickness of the Outer Nuclear Layer in the Treated Area Baseline	59.30 µm Standard Deviation 13.50
The Thickness of the Outer Nuclear Layer in the Treated Area 4 weeks	64.75 µm Standard Deviation 12.31
The Thickness of the Outer Nuclear Layer in the Treated Area 12 weeks	67.75 µm Standard Deviation 15.52

SECONDARY outcome

Timeframe: 4 weeks and 12 weeks

Adverse and Serious Adverse Events were recorded

Outcome measures

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Number of Partecipants With Adverse and Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 4 weeks and 12 weeks

Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas

Outcome measures

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas	0 Participants

SECONDARY outcome

Timeframe: 4 weeks and 12 weeks

Intraocular pressure was recorded.

Outcome measures

Measure	Pseudodrusen n=20 Participants Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.
Intraocular Pressure Baseline	15.5 mmHg Standard Deviation 2.9
Intraocular Pressure 4 weeks	14.9 mmHg Standard Deviation 2.4
Intraocular Pressure 12 weeks	14.7 mmHg Standard Deviation 2.4

Adverse Events

Pseudodrusen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Giuseppe Querques

San Raffaele Hospital

Phone: 00390226434004

Email: querques.giuseppe@hsr.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place