Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02569892
• Collaborator: Bascom Palmer Eye Institute (Other)
• Enrollment: 19
• Location: 1
• Arms: 2
• Actual Duration (Months): 52.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration; Retinal Drusen	Device: Pascal Retinal Laser Photocoagulator	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser Arm Participants receive treatment with sub-threshold macular laser photocoagulation	Device: Pascal Retinal Laser Photocoagulator; Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
Sham Comparator: Sham Laser Arm Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)	Device: Pascal Retinal Laser Photocoagulator; Sub-threshold macular laser treatment with Pascal laser Endpoint Management System

Outcome Measures

Primary Outcome Measures

1. Change in Macular Drusen Volume [baseline, 6, 12, and 24 months]

   Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)

Secondary Outcome Measures

1. Change in Visual Acuity [baseline, 6, 12, and 24 months]

   Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart

2. Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV) [2 years]

   Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Older than 60 years of age.

2. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle

3. Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.

4. Able to give an informed consent.

Exclusion Criteria:

1. Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).

2. Previous macular laser treatment.

3. Any previous ocular condition that may be associated with a risk of developing macular oedema.

4. Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).

5. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.

6. Important known allergies to sodium fluorescein dye used in angiography.

7. Ocular or periocular infections.

8. Planned intra-ocular surgery within one year.

9. Patient is unavailable for follow-up visits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Byers Eye Institute at Stanford University	Palo Alto	California	United States	94303

Sponsors and Collaborators

• Stanford University
• Bascom Palmer Eye Institute

Investigators

• Principal Investigator: Steven Sanislo, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 15, 2018

More Information

Publications

None provided.

• Responsible Party: Steven R. Sanislo, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02569892
• Other Study ID Numbers: IRB-33991
• First Posted: Oct 7, 2015
• Last Update Posted: Oct 28, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Macular Degeneration; Retinal Drusen

Study Results

Participant Flow

Recruitment Details

Participants recruited from January 2016 until May 2018, at which time interim analysis revealed futility.

Pre-assignment Detail

19 participants signed informed consent; 2 participants failed screening, and 17 participants started the study. Participants may have contributed one or both eyes to the study. If both eyes were enrolled the first eye would be randomly assigned to treatment or sham, and the fellow eye would be assigned to the opposite treatment arm. Participants who contributed more than one eye are counted in more than one reporting group.

Arm/Group Title	Sub-threshold Macular Laser Photocoagulation	Sham Laser
Arm/Group Description	Participants that receive treatment with sub-threshold macular laser photocoagulation	Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Period Title: Overall Study
STARTED	10	9
COMPLETED	10	8
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants receive sub-threshold macular laser photocoagulation and/or sham treatment with power setting at zero
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 11.8%
>=65 years	15 88.2%
Sex: Female, Male (Count of Participants)
Female	11 64.7%
Male	6 35.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Change in Macular Drusen Volume
Description	Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)
Time Frame	baseline, 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Sub-threshold Macular Laser Photocoagulation	Sham Laser
Arm/Group Description	Participants that receive treatment with sub-threshold macular laser photocoagulation	Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Measure Participants	10	9
Measure Eyes	10	9
Baseline volume	0.05	0.11
6 month change	20.0	9.0
12 month change	42.2	27.2
24 month change	80.0	-4.5

2. Secondary Outcome

Title	Change in Visual Acuity
Description	Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart
Time Frame	baseline, 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Sub-threshold Macular Laser Photocoagulation	Sham Laser
Arm/Group Description	Participants that receive treatment with sub-threshold macular laser photocoagulation	Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Measure Participants	10	9
Measure Eyes	10	9
Baseline vision	81.7 (8.60)	79.4 (5.19)
6 month change	-0.7 (4.24)	-3.4 (4.67)
12 month change	-2.7 (324)	-0.9 (3.95)
24 month change	-3.6 (6.10)	-6.3 (6.96)

3. Secondary Outcome

Title	Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)
Description	Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Sub-threshold Macular Laser Photocoagulation	Sham Laser
Arm/Group Description	Participants that receive treatment with sub-threshold macular laser photocoagulation	Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Measure Participants	10	9
Measure Eyes	10	9
Count of Units [Eyes]	0	0

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	Per protocol, only adverse events related to treatment were collected. Participants who contributed more than one eye are counted in more than one reporting group.
Arm/Group Title	Sub-threshold Macular Laser Photocoagulation		Sham Laser
Arm/Group Description	Participants that receive treatment with sub-threshold macular laser photocoagulation		Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
All Cause Mortality
	Sub-threshold Macular Laser Photocoagulation		Sham Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)
Serious Adverse Events
	Sub-threshold Macular Laser Photocoagulation		Sham Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Sub-threshold Macular Laser Photocoagulation		Sham Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		0/9 (0%)
Eye disorders
mild supra-threshold laser burns	1/10 (10%)	1	0/9 (0%)	0

Limitations/Caveats

This study did not meet enrollment goal of 60 study eyes.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.