Age-Related Macular Degeneration, Geographic Atrophy, Reticular Pseudodrusen
Conditions
Keywords
Age-Related Macular Degeneration, Geographic Atrophy, Reticular pseudodrusen, Lasers, PASCAL 577
Brief summary
To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.
Interventions
PROCEDURESubthreshold 577 nm yellow wavelength laser photo-coagulator
Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed. The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.
Sponsors
Ospedale San Raffaele
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* GA \< 0.5 disk areas secondary to AMD and/or Reticular pseudodrusen * 50 years or older * The periphery of the atrophic lesions must demonstrate increased autofluorescence * Best corrected visual acuity between 20/20 and 20/400 inclusive * Clear ocular media * Ability to provide informed consent and attend all study visits
Exclusion criteria
* GA secondary to other causes aside from AMD * Evidence of choroidal neovascularization in either eye * Any prior treatment for AMD, aside from antioxidants * Any other ocular condition that would progress in the study period and confound visual acuity assessment * Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve * Presence of idiopathic or autoimmune-associated uveitis * Any intraocular surgery 3 months of entry * Any prior thermal laser in the macula * History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery * Previous therapeutic radiation in the ocular region in either eye * Any treatment with an investigational agent in the previous 60 days before study entry * Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment * Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline \[Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Sensitivity | Baseline, 4 weeks and 12 weeks | Change in retinal sensitivity on customized microperimetry (treated area). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline, 4 weeks and 12 weeks | Change in mean Visual Acuity |
| The Thickness of the Outer Nuclear Layer in the Treated Area | Baseline, 4 weeks and 12 weeks | The thickness of the outer nuclear layer in the treated area was measured using structural OCT |
| Number of Partecipants With Adverse and Serious Adverse Events | 4 weeks and 12 weeks | Adverse and Serious Adverse Events were recorded |
| Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas | 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 |
| Intraocular Pressure | 4 weeks and 12 weeks | Intraocular pressure was recorded. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pseudodrusen Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pseudodrusen |
|---|---|
| Age, Continuous | 78.4 Years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Italy | 20 participants |
| Retinal sensitivity in the treated area | 12.08 dB STANDARD_DEVIATION 4.65 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Retinal Sensitivity
Change in retinal sensitivity on customized microperimetry (treated area).
Time frame: Baseline, 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pseudodrusen | Retinal Sensitivity | Baseline | 12.08 dB | Standard Deviation 4.65 |
| Pseudodrusen | Retinal Sensitivity | 4 weeks | 11.08 dB | Standard Deviation 5.06 |
| Pseudodrusen | Retinal Sensitivity | 12 weeks | 11.45 dB | Standard Deviation 5.7 |
p-value: 0.404ANOVA
Secondary
Intraocular Pressure
Intraocular pressure was recorded.
Time frame: 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pseudodrusen | Intraocular Pressure | Baseline | 15.5 mmHg | Standard Deviation 2.9 |
| Pseudodrusen | Intraocular Pressure | 4 weeks | 14.9 mmHg | Standard Deviation 2.4 |
| Pseudodrusen | Intraocular Pressure | 12 weeks | 14.7 mmHg | Standard Deviation 2.4 |
p-value: 0.267ANOVA
Secondary
Number of Partecipants With Adverse and Serious Adverse Events
Adverse and Serious Adverse Events were recorded
Time frame: 4 weeks and 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pseudodrusen | Number of Partecipants With Adverse and Serious Adverse Events | 0 Participants |
Secondary
Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas
Time frame: 4 weeks and 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pseudodrusen | Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas | 0 Participants |
Secondary
The Thickness of the Outer Nuclear Layer in the Treated Area
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Time frame: Baseline, 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pseudodrusen | The Thickness of the Outer Nuclear Layer in the Treated Area | Baseline | 59.30 µm | Standard Deviation 13.5 |
| Pseudodrusen | The Thickness of the Outer Nuclear Layer in the Treated Area | 4 weeks | 64.75 µm | Standard Deviation 12.31 |
| Pseudodrusen | The Thickness of the Outer Nuclear Layer in the Treated Area | 12 weeks | 67.75 µm | Standard Deviation 15.52 |
p-value: 0.001ANOVA
Secondary
Visual Acuity
Change in mean Visual Acuity
Time frame: Baseline, 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pseudodrusen | Visual Acuity | Baseline | 0.14 LogMAR | Standard Deviation 0.09 |
| Pseudodrusen | Visual Acuity | 4 weeks | 0.135 LogMAR | Standard Deviation 0.1 |
| Pseudodrusen | Visual Acuity | 12 weeks | 0.115 LogMAR | Standard Deviation 0.09 |
p-value: 0.232ANOVA